Characterization of tissue irregularities through the use of mono-chromatic light refractivity

ABSTRACT

A surgical image acquisition system includes multiple illumination sources, each source emitting light at a specified wavelength, a light sensor to receive light reflected from a tissue sample illuminated by each of the illumination sources, and a computing system. The computing system may receive data from the light sensor when the tissue sample is illuminated by the illumination sources, and calculate structural data related to one or more characteristics of a structure within the tissue. The structural data may be a surface characteristic such as a surface roughness or a structure composition such as a collagen and elastin composition. The computer system may further transmit the structural data to a smart surgical device. The smart devices may include a smart stapler, a smart RF sealing device, or a smart ultrasonic cutting device. The system may include a controller and computer enabled instructions to accomplish the above.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. 119(e)to U.S. Provisional Patent Application Ser. No. 62/649,291, titled USEOF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OFBACK SCATTERED LIGHT, filed Mar. 28, 2018, the disclosure of which isherein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C.119(e) to U.S. Provisional Patent Application Ser. No. 62/611,341,titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, of U.S.Provisional Patent Application Ser. No. 62/611,340, titled CLOUD-BASEDMEDICAL ANALYTICS, filed Dec. 28, 2017, of U.S. Provisional PatentApplication Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

BACKGROUND

The present disclosure relates to various surgical systems. Surgicalprocedures are typically performed in surgical operating theaters orrooms in a healthcare facility such as, for example, a hospital. Asterile field is typically created around the patient. The sterile fieldmay include the scrubbed team members, who are properly attired, and allfurniture and fixtures in the area. Various surgical devices and systemsare utilized in performance of a surgical procedure.

SUMMARY

In some aspects, a surgical image acquisition system may include aplurality of illumination sources in which each illumination source isconfigured to emit light having a specified central wavelength, a lightsensor configured to receive a portion of the light reflected from atissue sample when illuminated by the one or more of the plurality ofillumination sources, and a computing system. The computing system isfurther configured to receive data from the light sensor when the tissuesample is illuminated by each of the plurality of illumination sources,calculate structural data related to a characteristic of a structurewithin the tissue sample based on the data received by the light sensorwhen the tissue sample is illuminated by each of the illuminationsources, and transmit the structural data related to the characteristicof the structure to be received by a smart surgical device. Thecharacteristic of the structure may be a surface characteristic or astructure composition.

In one aspect of the surgical image acquisition system, the plurality ofillumination sources may include at least one of a red lightillumination source, a green light illumination source, and a blue lightillumination source.

In one aspect of the surgical image acquisition, the plurality ofillumination sources may include at least one of an infrared lightillumination source and an ultraviolet light illumination source.

In one aspect of the surgical image acquisition system, the computingsystem, configured to calculate structural data related to acharacteristic of a structure within the tissue, may include a computingsystem configured to calculate structural data related to a compositionof a structure within the tissue.

In one aspect of the surgical image acquisition, the computing system,configured to calculate structural data related to a characteristic of astructure within the tissue, comprises a computing system configured tocalculate structural data related to a surface roughness of a structurewithin the tissue.

In some aspects, a surgical image acquisition system may include aprocessor and a memory coupled to the processor. The memory may storeinstructions executable by the processor to control the operation of aplurality of illumination sources of a tissue sample in which eachillumination source is configured to emit light having a specifiedcentral wavelength, to receive data from the light sensor when thetissue sample is illuminated by each of the plurality of illuminationsources, to calculate structural data related to a characteristic of astructure within the tissue sample based on the data received by thelight sensor when the tissue sample is illuminated by each of theillumination sources, and to transmit the structural data related to thecharacteristic of the structure to be received by a smart surgicaldevice. In some aspects, the characteristic of the structure may be asurface characteristic or a structure composition.

In one aspect of the surgical image acquisition system, the instructionsexecutable by the processor to control the operation of a plurality ofillumination sources comprise one or more instructions to illuminate thetissue sample sequentially by each of the plurality of illuminationsources.

In one aspect of the surgical image acquisition system, the instructionsexecutable by the processor to calculate structural data related to acharacteristic of a structure within the tissue sample based on the datareceived by the light sensor may include one or more instructions tocalculate structural data related to a characteristic of a structurewithin the tissue sample based on a phase shift in the illuminationreflected by the tissue sample.

In one aspect of the surgical image acquisition system, the structurecomposition may include a relative composition of collagen and elastinin a tissue.

In one aspect of the surgical image acquisition system, the structurecomposition may include an amount of hydration of a tissue.

In some aspects, a surgical image acquisition system may include acontrol circuit configured to control the operation of a plurality ofillumination sources of a tissue sample in which each illuminationsource is configured to emit light having a specified centralwavelength, to receive data from the light sensor when the tissue sampleis illuminated by each of the plurality of illumination sources, tocalculate structural data related to a characteristic of a structurewithin the tissue sample based on the data received by the light sensorwhen the tissue sample is illuminated by each of the illuminationsources, and to transmit the structural data related to thecharacteristic of the structure to be received by a smart surgicaldevice. In some aspects, the characteristic of the structure may be asurface characteristic or a structure composition.

In one aspect of the surgical image acquisition system, the controlcircuit is configured to transmit the structural data related to thecharacteristic of the structure to be received by a smart surgicaldevice wherein the smart surgical device is a smart surgical stapler.

In one aspect of the surgical image acquisition system, the controlcircuit is further configured to transmit data related to an anvilpressure based on the characteristic of the structure to be received bythe smart surgical stapler.

In one aspect of the surgical image acquisition system, the controlcircuit is configured to transmit the structural data related to thecharacteristic of the structure to be received by a smart surgicaldevice wherein the smart surgical device is a smart surgical RF sealingdevice.

In one aspect of the surgical image acquisition system, the controlcircuit is further configured to transmit data related to an amount ofRF power based on the characteristic of the structure to be received bythe smart RF sealing device.

In one aspect of the surgical image acquisition system, the controlcircuit is configured to transmit the structural data related to thecharacteristic of the structure to be received by a smart surgicaldevice wherein the smart surgical device is a smart ultrasound cuttingdevice.

In one aspect of the surgical image acquisition system, the controlcircuit is further configured to transmit data related to an amount ofpower provided to an ultrasonic transducer or a driving frequency of theultrasonic transducer based on the characteristic of the structure to bereceived by the ultrasound cutting device.

In some aspects, a non-transitory computer readable medium storingcomputer readable instructions which, when executed, causes a machine tocontrol the operation of a plurality of illumination sources of a tissuesample wherein each illumination source is configured to emit lighthaving a specified central wavelength, to receive data from the lightsensor when the tissue sample is illuminated by each of the plurality ofillumination sources, to calculate structural data related to acharacteristic of a structure within the tissue sample based on the datareceived by the light sensor when the tissue sample is illuminated byeach of the illumination sources, and to transmit the structural datarelated to the characteristic of the structure to be received by a smartsurgical device. In some aspects, the characteristic of the structure isa surface characteristic or a structure composition.

FIGURES

The features of various aspects are set forth with particularity in theappended claims. The various aspects, however, both as to organizationand methods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing configured to receivea plurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 7 illustrates a vertical modular housing configured to receive aplurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 11 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure.

FIG. 13 illustrates a control circuit configured to control aspects ofthe surgical instrument or tool, in accordance with at least one aspectof the present disclosure.

FIG. 14 illustrates a combinational logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 15 illustrates a sequential logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions, inaccordance with at least one aspect of the present disclosure.

FIG. 17 is a schematic diagram of a robotic surgical instrumentconfigured to operate a surgical tool described herein, in accordancewith at least one aspect of the present disclosure.

FIG. 18 illustrates a block diagram of a surgical instrument programmedto control the distal translation of a displacement member, inaccordance with at least one aspect of the present disclosure.

FIG. 19 is a schematic diagram of a surgical instrument configured tocontrol various functions, in accordance with at least one aspect of thepresent disclosure.

FIG. 20 is a simplified block diagram of a generator configured toprovide inductorless tuning, among other benefits, in accordance with atleast one aspect of the present disclosure.

FIG. 21 illustrates an example of a generator, which is one form of thegenerator of FIG. 20 , in accordance with at least one aspect of thepresent disclosure.

FIG. 22A illustrates a visualization system that may be incorporatedinto a surgical system, in accordance with at least one aspect of thepresent disclosure.

FIG. 22B illustrates a top plan view of a hand unit of the visualizationsystem of FIG. 22A, in accordance with at least one aspect of thepresent disclosure.

FIG. 22C illustrates a side plan view of the hand unit depicted in FIG.22A along with an imaging sensor disposed therein, in accordance with atleast one aspect of the present disclosure.

FIG. 22D illustrates a plurality of an imaging sensors a depicted inFIG. 22C, in accordance with at least one aspect of the presentdisclosure.

FIG. 23A illustrates a plurality of laser emitters that may beincorporated in the visualization system of FIG. 22A, in accordance withat least one aspect of the present disclosure.

FIG. 23B illustrates illumination of an image sensor having a Bayerpattern of color filters, in accordance with at least one aspect of thepresent disclosure.

FIG. 23C illustrates a graphical representation of the operation of apixel array for a plurality of frames, in accordance with at least oneaspect of the present disclosure.

FIG. 23D illustrates a schematic of an example of an operation sequenceof chrominance and luminance frames, in accordance with at least oneaspect of the present disclosure.

FIG. 23E illustrates an example of sensor and emitter patterns, inaccordance with at least one aspect of the present disclosure.

FIG. 23F illustrates a graphical representation of the operation of apixel array, in accordance with at least one aspect of the presentdisclosure.

FIG. 24 illustrates a schematic of one example of instrumentation forNIR spectroscopy, according to one aspect of the present disclosure.

FIG. 25 illustrates schematically one example of instrumentation fordetermining NIRS based on Fourier transform infrared imaging, inaccordance with at least one aspect of the present disclosure.

FIGS. 26A-C illustrate a change in wavelength of light scattered frommoving blood cells, in accordance with at least one aspect of thepresent disclosure.

FIG. 27 illustrates an aspect of instrumentation that may be used todetect a Doppler shift in laser light scattered from portions of atissue, in accordance with at least one aspect of the presentdisclosure.

FIG. 28 illustrates schematically some optical effects on lightimpinging on a tissue having subsurface structures, in accordance withat least one aspect of the present disclosure.

FIG. 29 illustrates an example of the effects on a Doppler analysis oflight impinging on a tissue sample having subsurface structures, inaccordance with at least one aspect of the present disclosure.

FIGS. 30A-C illustrate schematically the detection of moving blood cellsat a tissue depth based on a laser Doppler analysis at a variety oflaser wavelengths, in accordance with at least one aspect of the presentdisclosure.

FIG. 30D illustrates the effect of illuminating a CMOS imaging sensorwith a plurality of light wavelengths over time, in accordance with atleast one aspect of the present disclosure.

FIG. 31 illustrates an example of a use of Doppler imaging to detect thepresent of subsurface blood vessels, in accordance with at least oneaspect of the present disclosure.

FIG. 32 illustrates a method to identify a subsurface blood vessel basedon a Doppler shift of blue light due to blood cells flowingtherethrough, in accordance with at least one aspect of the presentdisclosure.

FIG. 33 illustrates schematically localization of a deep subsurfaceblood vessel, in accordance with at least one aspect of the presentdisclosure.

FIG. 34 illustrates schematically localization of a shallow subsurfaceblood vessel, in accordance with at least one aspect of the presentdisclosure.

FIG. 35 illustrates a composite image comprising a surface image and animage of a subsurface blood vessel, in accordance with at least oneaspect of the present disclosure.

FIG. 36 is a flow chart of a method for determining a depth of a surfacefeature in a piece of tissue, in accordance with at least one aspect ofthe present disclosure.

FIG. 37 illustrates the effect of the location and characteristics ofnon-vascular structures on light impinging on a tissue sample, inaccordance with at least one aspect of the present disclosure.

FIG. 38 schematically depicts one example of components used in a fullfield OCT device, in accordance with at least one aspect of the presentdisclosure.

FIG. 39 illustrates schematically the effect of tissue anomalies onlight reflected from a tissue sample, in accordance with at least oneaspect of the present disclosure.

FIG. 40 illustrates an image display derived from a combination oftissue visualization modalities, in accordance with at least one aspectof the present disclosure.

FIGS. 41A-C illustrate several aspects of displays that may be providedto a surgeon for a visual identification of a combination of surface andsub-surface structures of a tissue in a surgical site, in accordancewith at least one aspect of the present disclosure.

FIG. 42 is a flow chart of a method for providing information related toa characteristic of a tissue to a smart surgical instrument, inaccordance with at least one aspect of the present disclosure.

FIGS. 43A and 43B illustrate a multi-pixel light sensor receiving bylight reflected by a tissue illuminated by sequential exposure to red,green, blue, and infra red light, and red, green, blue, and ultravioletlaser light sources, respectively, in accordance with at least oneaspect of the present disclosure.

FIGS. 44A and 44B illustrate the distal end of an elongated camera probehaving a single light sensor and two light sensors, respectively, inaccordance with at least one aspect of the present disclosure.

FIG. 44C illustrates a perspective view of an example of a monolithicsensor having a plurality of pixel arrays, in accordance with at leastone aspect of the present disclosure.

FIG. 45 illustrates one example of a pair of fields of view available totwo image sensors of an elongated camera probe, in accordance with atleast one aspect of the present disclosure.

FIGS. 46A-D illustrate additional examples of a pair of fields of viewavailable to two image sensors of an elongated camera probe, inaccordance with at least one aspect of the present disclosure.

FIGS. 47A-C illustrate an example of the use of an imaging systemincorporating the features disclosed in FIG. 46D, in accordance with atleast one aspect of the present disclosure.

FIGS. 48A and 48B depict another example of the use of a dual imagingsystem, in accordance with at least one aspect of the presentdisclosure.

FIGS. 49A-C illustrate examples of a sequence of surgical steps whichmay benefit from the use of multi-image analysis at the surgical site,in accordance with at least one aspect of the present disclosure.

FIG. 50 is a timeline depicting situational awareness of a surgical hub,in accordance with at least one aspect of the present disclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 28, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/649,302, titled        INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION        CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/649,294, titled        DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. Provisional Patent Application Ser. No. 62/649,300, titled        SURGICAL HUB SITUATIONAL AWARENESS;    -   U.S. Provisional Patent Application Ser. No. 62/649,309, titled        SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING        THEATER;    -   U.S. Provisional Patent Application Ser. No. 62/649,310, titled        COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,291, titled        USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE        PROPERTIES OF BACK SCATTERED LIGHT;    -   U.S. Provisional Patent Application Ser. No. 62/649,296, titled        ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,333, titled        CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND        RECOMMENDATIONS TO A USER;    -   U.S. Provisional Patent Application Ser. No. 62/649,327, titled        CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION        TRENDS AND REACTIVE MEASURES;    -   U.S. Provisional Patent Application Ser. No. 62/649,315, titled        DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. Provisional Patent Application Ser. No. 62/649,313, titled        CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,320, titled        DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,307, titled        AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; and    -   U.S. Provisional Patent Application Ser. No. 62/649,323, titled        SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. PatentApplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE        SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES; now        U.S. Pat. No. 10,944,728;    -   U.S. patent application Ser. No. 15/940,648, titled INTERACTIVE        SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA        CAPABILITIES; now U.S. Pat. No. 11,069,012;    -   U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUB        COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES; now U.S. Pat. No. 11,166,772;    -   U.S. patent application Ser. No. 15/940,666, titled SPATIAL        AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS; now U.S. Pat. No.        11,678,881;    -   U.S. patent application Ser. No. 15/940,670, titled COOPERATIVE        UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY        INTELLIGENT SURGICAL HUBS; now U.S. Pat. No. 11,266,468;    -   U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB        CONTROL ARRANGEMENTS; now U.S. Pat. No. 10,987,178;    -   U.S. patent application Ser. No. 15/940,632, titled DATA        STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD; now U.S. Pat. No. 11,132,462.    -   U.S. patent application Ser. No. 15/940,640, titled        COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND        STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED        ANALYTICS SYSTEMS; now U.S. Pat. No. 11,202,570;    -   U.S. patent application Ser. No. 15/940,645, titled SELF        DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT; now        U.S. Pat. No. 10,892,899;    -   U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING        TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME; now        U.S. Patent Application Publication No. 2019/0205567;    -   U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUB        SITUATIONAL AWARENESS; now U.S. Patent Application Publication        No. 2019/0201140;    -   U.S. patent application Ser. No. 15/940,663, titled SURGICAL        SYSTEM DISTRIBUTED PROCESSING; now U.S. Pat. No. 11,419,630;    -   U.S. patent application Ser. No. 15/940,668, titled AGGREGATION        AND REPORTING OF SURGICAL HUB DATA; now U.S. Patent No.        2019/0201115;    -   U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB        SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER; now        U.S. Patent Application Publication No. 2019/0201104;    -   U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF        ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE; now        U.S. Pat. No. 11,026,751;    -   U.S. patent application Ser. No. 15/940,700, titled STERILE        FIELD INTERACTIVE CONTROL DISPLAYS; now U.S. Pat. No.        11,672,605;    -   U.S. patent application Ser. No. 15/940,629, titled COMPUTER        IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS; now U.S. Patent        Application Publication No. 2019/0201112;    -   U.S. patent application Ser. No. 15/940,704; titled USE OF LASER        LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF        BACK SCATTERED LIGHT; now U.S. Pat. No. 11,100,631; and    -   U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS        ARRAY IMAGING; Now U.S. Patent Application Publication No.        2019/0200906:

Applicant of the present application owns the following U.S. PatentApplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES; now U.S. Pat. No.        11,410,259;    -   U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL HUBS; now U.S. Pat. No.        11,076,921;    -   U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED        MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A        USER; now U.S. Patent Application Publication No. 2019/0206555;    -   U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED        MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE        RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET; now U.S. Pat.        No. 10,932,872;    -   U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED        MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED        INDIVIDUALIZATION OF INSTRUMENT FUNCTION; now U.S. Pat. No.        10,966,791;    -   U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED        MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND        REACTIVE MEASURES; now U.S. Pat. No. 11,179,208;    -   U.S. patent application Ser. No. 15/940,706, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; now        U.S. Patent Application Publication No. 2019/0206561; and    -   U.S. patent application Ser. No. 15/940,675, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES; Now U.S. Pat. No.        10,849,697,

Applicant of the present application owns the following U.S. PatentApplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,627, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; now U.S.        Pat. No. 11,013,563;    -   U.S. patent application Ser. No. 15/940,637, titled        COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; U.S. Patent Application Publication No. 2019/0201139;    -   U.S. patent application Ser. No. 15/940,642, titled CONTROLS FOR        ROBOT-ASSISTED SURGICAL PLATFORMS; now U.S. Patent Application        Publication No. 2019/0201113;    -   U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC        TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; now U.S.        Patent Application Publication No. 2019/0201142;    -   U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS        FOR ROBOT-ASSISTED SURGICAL PLATFORMS; now U.S. Pat. No.        11,213,359;    -   U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE        SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; now U.S.        Pat. No. 11,058,498;    -   U.S. patent application Ser. No. 15/940,690, titled DISPLAY        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; now U.S.        Patent Application Publication No. 2019/0201118; and    -   U.S. patent application Ser. No. 15/940,711, titled SENSING        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; now U.S.        Pat. No. 11,432,885.

Before explaining various aspects of surgical devices and generators indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Referring to FIG. 1 , a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1 , thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P are integers greater than or equal to one.

FIG. 3 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2 . In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2 , a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnap-shot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snap-shot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snap-shotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2 , a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety. A diagnostic input or feedback entered by anon-sterile operator at the visualization tower 111 can be routed by thehub 106 to the surgical instrument display 115 within the sterile field,where it can be viewed by the operator of the surgical instrument 112.Example surgical instruments that are suitable for use with the surgicalsystem 102 are described under the heading “Surgical InstrumentHardware” and in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety, for example.

Referring now to FIG. 3 , a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, and a storage array 134. In certainaspects, as illustrated in FIG. 3 , the hub 106 further includes a smokeevacuation module 126 and/or a suction/irrigation module 128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module 140 slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module 140 includes two or more of an ultrasonic energygenerator component 141, a bipolar RF energy generator component 144,and a monopolar RF energy generator component 142 that are housed in asingle unit. In one aspect, the combo generator module 140 also includesa smoke evacuation component, at least one energy delivery cable forconnecting the combo generator module 140 to a surgical instrument, atleast one smoke evacuation component configured to evacuate smoke,fluid, and/or particulates generated by the application of therapeuticenergy to the tissue, and a fluid line extending from the remotesurgical site to the smoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator 144can be used to seal the tissue while an ultrasonic generator 141 can beused to cut the sealed tissue. Aspects of the present disclosure presenta solution where a hub modular enclosure 136 is configured toaccommodate different generators, and facilitate an interactivecommunication therebetween. One of the advantages of the hub modularenclosure 136 is enabling the quick removal and/or replacement ofvarious modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts.

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7 , aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5 , the generator module 140 can be a generatormodule with integrated monopolar 142, bipolar 144, and ultrasonic 141components supported in a single housing unit 139 slidably insertableinto the hub modular enclosure 136. As illustrated in FIG. 5 , thegenerator module 140 can be configured to connect to a monopolar device146, a bipolar device 147, and an ultrasonic device 148. Alternatively,the generator module 140 may comprise a series of monopolar 142, bipolar144, and/or ultrasonic 141 generator modules that interact through thehub modular enclosure 136. The hub modular enclosure 136 can beconfigured to facilitate the insertion of multiple generators andinteractive communication between the generators docked into the hubmodular enclosure 136 so that the generators would act as a singlegenerator

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5 .

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4 , thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4 , the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing 160 configured toreceive a plurality of modules of a surgical hub 206. The lateralmodular housing 160 is configured to laterally receive and interconnectthe modules 161. The modules 161 are slidably inserted into dockingstations 162 of lateral modular housing 160, which includes a backplanefor interconnecting the modules 161. As illustrated in FIG. 6 , themodules 161 are arranged laterally in the lateral modular housing 160.Alternatively, the modules 161 may be arranged vertically in a lateralmodular housing.

FIG. 7 illustrates a vertical modular housing 164 configured to receivea plurality of modules 165 of the surgical hub 106. The modules 165 areslidably inserted into docking stations, or drawers, 167 of verticalmodular housing 164, which includes a backplane for interconnecting themodules 165. Although the drawers 167 of the vertical modular housing164 are arranged vertically, in certain instances, a vertical modularhousing 164 may include drawers that are arranged laterally.Furthermore, the modules 165 may interact with one another through thedocking ports of the vertical modular housing 164. In the example ofFIG. 7 , a display 177 is provided for displaying data relevant to theoperation of the modules 165. In addition, the vertical modular housing164 includes a master module 178 housing a plurality of sub-modules thatare slidably received in the master module 178.

In various aspects, the imaging module 138 comprises an integrated videoprocessor and a modular light source and is adapted for use with variousimaging devices. In one aspect, the imaging device is comprised of amodular housing that can be assembled with a light source module and acamera module. The housing can be a disposable housing. In at least oneexample, the disposable housing is removably coupled to a reusablecontroller, a light source module, and a camera module. The light sourcemodule and/or the camera module can be selectively chosen depending onthe type of surgical procedure. In one aspect, the camera modulecomprises a CCD sensor. In another aspect, the camera module comprises aCMOS sensor. In another aspect, the camera module is configured forscanned beam imaging. Likewise, the light source module can beconfigured to deliver a white light or a different light, depending onthe surgical procedure.

During a surgical procedure, removing a surgical device from thesurgical field and replacing it with another surgical device thatincludes a different camera or a different light source can beinefficient. Temporarily losing sight of the surgical field may lead toundesirable consequences. The module imaging device of the presentdisclosure is configured to permit the replacement of a light sourcemodule or a camera module midstream during a surgical procedure, withouthaving to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing thatincludes a plurality of channels. A first channel is configured toslidably receive the camera module, which can be configured for asnap-fit engagement with the first channel. A second channel isconfigured to slidably receive the light source module, which can beconfigured for a snap-fit engagement with the second channel. In anotherexample, the camera module and/or the light source module can be rotatedinto a final position within their respective channels. A threadedengagement can be employed in lieu of the snap-fit engagement.

In various examples, multiple imaging devices are placed at differentpositions in the surgical field to provide multiple views. The imagingmodule 138 can be configured to switch between the imaging devices toprovide an optimal view. In various aspects, the imaging module 138 canbe configured to integrate the images from the different imaging device.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on Dec. 15,2011, and U.S. Patent Application Publication No. 2014/0243597, titledSYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, whichpublished on Aug. 28, 2014, each of which is herein incorporated byreference in its entirety.

FIG. 8 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/internet protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9 ) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to W-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 9 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 10 , the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 9 , themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 10 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 10 , themodular communication hub 203 may be connected in a tiered configurationto expand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 10 , each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety, in which the sensor module is configured todetermine the size of the operating theater and to adjustBluetooth-pairing distance limits. A laser-based non-contact sensormodule scans the operating theater by transmitting laser light pulses,receiving laser light pulses that bounce off the perimeter walls of theoperating theater, and comparing the phase of the transmitted pulse tothe received pulse to determine the size of the operating theater and toadjust Bluetooth pairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4×, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10 , the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10 , may comprise an image processor, image processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 11 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, according to one aspect of the presentdisclosure. In the illustrated aspect, the USB network hub device 300employs a TUSB2036 integrated circuit hub by Texas Instruments. The USBnetwork hub 300 is a CMOS device that provides an upstream USBtransceiver port 302 and up to three downstream USB transceiver ports304, 306, 308 in compliance with the USB 2.0 specification. The upstreamUSB transceiver port 302 is a differential root data port comprising adifferential data minus (DM0) input paired with a differential data plus(DP0) input. The three downstream USB transceiver ports 304, 306, 308are differential data ports where each port includes differential dataplus (DP1-DP3) outputs paired with differential data minus (DM1-DM3)outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Surgical Instrument Hardware

FIG. 12 illustrates a logic diagram of a control system 470 of asurgical instrument or tool in accordance with one or more aspects ofthe present disclosure. The system 470 comprises a control circuit. Thecontrol circuit includes a microcontroller 461 comprising a processor462 and a memory 468. One or more of sensors 472, 474, 476, for example,provide real-time feedback to the processor 462. A motor 482, driven bya motor driver 492, operably couples a longitudinally movabledisplacement member to drive the I-beam knife element. A tracking system480 is configured to determine the position of the longitudinallymovable displacement member. The position information is provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of a firing member, firing bar, and I-beam knife element.Additional motors may be provided at the tool driver interface tocontrol I-beam firing, closure tube travel, shaft rotation, andarticulation. A display 473 displays a variety of operating conditionsof the instruments and may include touch screen functionality for datainput. Information displayed on the display 473 may be overlaid withimages acquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4×, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the microcontroller 461 includes aprocessor 462 and a memory 468. The electric motor 482 may be a brusheddirect current (DC) motor with a gearbox and mechanical links to anarticulation or knife system. In one aspect, a motor driver 492 may bean A3941 available from Allegro Microsystems, Inc. Other motor driversmay be readily substituted for use in the tracking system 480 comprisingan absolute positioning system. A detailed description of an absolutepositioning system is described in U.S. Patent Application PublicationNo. 2017/0296213, titled SYSTEMS AND METHODS FOR CONTROLLING A SURGICALSTAPLING AND CUTTING INSTRUMENT, which published on Oct. 19, 2017, whichis herein incorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response iscompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response is a favorable, tuned value that balances the smooth,continuous nature of the simulated response with the measured response,which can detect outside influences on the system.

In one aspect, the motor 482 may be controlled by the motor driver 492and can be employed by the firing system of the surgical instrument ortool. In various forms, the motor 482 may be a brushed DC driving motorhaving a maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable. In at least one example, the batterycells can be lithium-ion batteries which can be couplable to andseparable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 is a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 comprises a unique charge pump regulatorthat provides full (>10 V) gate drive for battery voltages down to 7 Vand allows the A3941 to operate with a reduced gate drive, down to 5.5V. A bootstrap capacitor may be employed to provide the above batterysupply voltage required for N-channel MOSFETs. An internal charge pumpfor the high-side drive allows DC (100% duty cycle) operation. The fullbridge can be driven in fast or slow decay modes using diode orsynchronous rectification. In the slow decay mode, current recirculationcan be through the high-side or the lowside FETs. The power FETs areprotected from shoot-through by resistor-adjustable dead time.Integrated diagnostics provide indications of undervoltage,overtemperature, and power bridge faults and can be configured toprotect the power MOSFETs under most short circuit conditions. Othermotor drivers may be readily substituted for use in the tracking system480 comprising an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuitarrangement comprising a position sensor 472 according to one aspect ofthis disclosure. The position sensor 472 for an absolute positioningsystem provides a unique position signal corresponding to the locationof a displacement member. In one aspect, the displacement memberrepresents a longitudinally movable drive member comprising a rack ofdrive teeth for meshing engagement with a corresponding drive gear of agear reducer assembly. In other aspects, the displacement memberrepresents the firing member, which could be adapted and configured toinclude a rack of drive teeth. In yet another aspect, the displacementmember represents a firing bar or the I-beam, each of which can beadapted and configured to include a rack of drive teeth. Accordingly, asused herein, the term displacement member is used generically to referto any movable member of the surgical instrument or tool such as thedrive member, the firing member, the firing bar, the I-beam, or anyelement that can be displaced. In one aspect, the longitudinally movabledrive member is coupled to the firing member, the firing bar, and theI-beam. Accordingly, the absolute positioning system can, in effect,track the linear displacement of the I-beam by tracking the lineardisplacement of the longitudinally movable drive member. In variousother aspects, the displacement member may be coupled to any positionsensor 472 suitable for measuring linear displacement. Thus, thelongitudinally movable drive member, the firing member, the firing bar,or the I-beam, or combinations thereof, may be coupled to any suitablelinear displacement sensor. Linear displacement sensors may includecontact or non-contact displacement sensors. Linear displacement sensorsmay comprise linear variable differential transformers (LVDT),differential variable reluctance transducers (DVRT), a slidepotentiometer, a magnetic sensing system comprising a movable magnet anda series of linearly arranged Hall effect sensors, a magnetic sensingsystem comprising a fixed magnet and a series of movable, linearlyarranged Hall effect sensors, an optical sensing system comprising amovable light source and a series of linearly arranged photo diodes orphoto detectors, an optical sensing system comprising a fixed lightsource and a series of movable linearly, arranged photo diodes or photodetectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source supplies power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member represents thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member represents thelongitudinally movable firing member, firing bar, I-beam, orcombinations thereof.

A single revolution of the sensor element associated with the positionsensor 472 is equivalent to a longitudinal linear displacement d1 of theof the displacement member, where d1 is the longitudinal linear distancethat the displacement member moves from point “a” to point “b” after asingle revolution of the sensor element coupled to the displacementmember. The sensor arrangement may be connected via a gear reductionthat results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches are fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d1+d2+ . .. dn of the displacement member. The output of the position sensor 472is provided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors encompass many aspects of physics and electronics. Thetechnologies used for magnetic field sensing include search coil,fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect,anisotropic magnetoresistance, giant magnetoresistance, magnetic tunneljunctions, giant magnetoimpedance, magnetostrictive/piezoelectriccomposites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic,and microelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system comprises a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 is a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that is located above a magnet. A high-resolution ADC and a smart powermanagement controller are also provided on the chip. A coordinaterotation digital computer (CORDIC) processor, also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface, such as a serial peripheral interface (SPI) interface, to themicrocontroller 461. The position sensor 472 provides 12 or 14 bits ofresolution. The position sensor 472 may be an AS5055 chip provided in asmall QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. patent application Ser. No.15/628,175, titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OFA SURGICAL STAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, whichis herein incorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system takes into account propertieslike mass, inertial, viscous friction, inductance resistance, etc., topredict what the states and outputs of the physical system will be byknowing the input.

The absolute positioning system provides an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, is configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain is converted toa digital signal and provided to the processor 462. Alternatively, or inaddition to the sensor 474, a sensor 476, such as, for example, a loadsensor, can measure the closure force applied by the closure drivesystem to the anvil. The sensor 476, such as, for example, a loadsensor, can measure the firing force applied to an I-beam in a firingstroke of the surgical instrument or tool. The I-beam is configured toengage a wedge sled, which is configured to upwardly cam staple driversto force out staples into deforming contact with an anvil. The I-beamalso includes a sharpened cutting edge that can be used to sever tissueas the I-beam is advanced distally by the firing bar. Alternatively, acurrent sensor 478 can be employed to measure the current drawn by themotor 482. The force required to advance the firing member cancorrespond to the current drawn by the motor 482, for example. Themeasured force is converted to a digital signal and provided to theprocessor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector comprises a strain gauge sensor474, such as, for example, a micro-strain gauge, that is configured tomeasure one or more parameters of the end effector, for example. In oneaspect, the strain gauge sensor 474 can measure the amplitude ormagnitude of the strain exerted on a jaw member of an end effectorduring a clamping operation, which can be indicative of the tissuecompression. The measured strain is converted to a digital signal andprovided to a processor 462 of the microcontroller 461. A load sensor476 can measure the force used to operate the knife element, forexample, to cut the tissue captured between the anvil and the staplecartridge. A magnetic field sensor can be employed to measure thethickness of the captured tissue. The measurement of the magnetic fieldsensor also may be converted to a digital signal and provided to theprocessor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub as shown in FIGS. 8-11 .

FIG. 13 illustrates a control circuit 500 configured to control aspectsof the surgical instrument or tool according to one aspect of thisdisclosure. The control circuit 500 can be configured to implementvarious processes described herein. The control circuit 500 may comprisea microcontroller comprising one or more processors 502 (e.g.,microprocessor, microcontroller) coupled to at least one memory circuit504. The memory circuit 504 stores machine-executable instructions that,when executed by the processor 502, cause the processor 502 to executemachine instructions to implement various processes described herein.The processor 502 may be any one of a number of single-core or multicoreprocessors known in the art. The memory circuit 504 may comprisevolatile and non-volatile storage media. The processor 502 may includean instruction processing unit 506 and an arithmetic unit 508. Theinstruction processing unit may be configured to receive instructionsfrom the memory circuit 504 of this disclosure.

FIG. 14 illustrates a combinational logic circuit 510 configured tocontrol aspects of the surgical instrument or tool according to oneaspect of this disclosure. The combinational logic circuit 510 can beconfigured to implement various processes described herein. Thecombinational logic circuit 510 may comprise a finite state machinecomprising a combinational logic 512 configured to receive dataassociated with the surgical instrument or tool at an input 514, processthe data by the combinational logic 512, and provide an output 516.

FIG. 15 illustrates a sequential logic circuit 520 configured to controlaspects of the surgical instrument or tool according to one aspect ofthis disclosure. The sequential logic circuit 520 or the combinationallogic 522 can be configured to implement various processes describedherein. The sequential logic circuit 520 may comprise a finite statemachine. The sequential logic circuit 520 may comprise a combinationallogic 522, at least one memory circuit 524, and a clock 529, forexample. The at least one memory circuit 524 can store a current stateof the finite state machine. In certain instances, the sequential logiccircuit 520 may be synchronous or asynchronous. The combinational logic522 is configured to receive data associated with the surgicalinstrument or tool from an input 526, process the data by thecombinational logic 522, and provide an output 528. In other aspects,the circuit may comprise a combination of a processor (e.g., processor502, FIG. 13 ) and a finite state machine to implement various processesherein. In other aspects, the finite state machine may comprise acombination of a combinational logic circuit (e.g., combinational logiccircuit 510, FIG. 14 ) and the sequential logic circuit 520.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on. Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing, closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea firing motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604 which can be configured to transmitfiring motions, generated by the motor 602 to the end effector, inparticular to displace the I-beam element. In certain instances, thefiring motions generated by the motor 602 may cause the staples to bedeployed from the staple cartridge into tissue captured by the endeffector and/or the cutting edge of the I-beam element to be advanced tocut the captured tissue, for example. The I-beam element may beretracted by reversing the direction of the motor 602.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605 which can be configured to transmitclosure motions, generated by the motor 603 to the end effector, inparticular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motionsmay cause the end effector to transition from an open configuration toan approximated configuration to capture tissue, for example. The endeffector may be transitioned to an open position by reversing thedirection of the motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The motors 606 a,606 b may be operably coupled to respective articulation motor driveassemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the motors 606 a, 606 b to the endeffector. In certain instances, the articulation motions may cause theend effector to articulate relative to the shaft, for example.

As described above, the surgical instrument or tool may include aplurality of motors which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube and the I-beam element toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610 which can be employed with a plurality ofmotors of the surgical instrument or tool. In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 16 , a switch 614 can be moved or transitioned between a pluralityof positions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulations motor 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 16 , the common controlmodule 610 may comprise a motor driver 626 which may comprise one ormore H-Bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed above.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory units 624 may be coupled to the processor 622,for example.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as a lithium-ion battery, for example. In certaininstances, the battery pack may be configured to be releasably mountedto a handle for supplying power to the surgical instrument 600. A numberof battery cells connected in series may be used as the power source628. In certain instances, the power source 628 may be replaceableand/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor is a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. It isan example of sequential digital logic, as it has internal memory.Processors operate on numbers and symbols represented in the binarynumeral system.

In one instance, the processor 622 may be any single-core or multicoreprocessor such as those known under the trade name ARM Cortex by TexasInstruments. In certain instances, the microcontroller 620 may be an LM4F230H5QR, available from Texas Instruments, for example. In at leastone example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4FProcessor Core comprising an on-chip memory of 256 KB single-cycle flashmemory, or other non-volatile memory, up to 40 MHz, a prefetch buffer toimprove performance above 40 MHz, a 32 KB single-cycle SRAM, an internalROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

In certain instances, the memory 624 may include program instructionsfor controlling each of the motors of the surgical instrument 600 thatare couplable to the common control module 610. For example, the memory624 may include program instructions for controlling the firing motor602, the closure motor 603, and the articulation motors 606 a, 606 b.Such program instructions may cause the processor 622 to control thefiring, closure, and articulation functions in accordance with inputsfrom algorithms or control programs of the surgical instrument or tool.

In certain instances, one or more mechanisms and/or sensors such as, forexample, sensors 630 can be employed to alert the processor 622 to theprogram instructions that should be used in a particular setting. Forexample, the sensors 630 may alert the processor 622 to use the programinstructions associated with firing, closing, and articulating the endeffector. In certain instances, the sensors 630 may comprise positionsensors which can be employed to sense the position of the switch 614,for example. Accordingly, the processor 622 may use the programinstructions associated with firing the I-beam of the end effector upondetecting, through the sensors 630 for example, that the switch 614 isin the first position 616; the processor 622 may use the programinstructions associated with closing the anvil upon detecting, throughthe sensors 630 for example, that the switch 614 is in the secondposition 617; and the processor 622 may use the program instructionsassociated with articulating the end effector upon detecting, throughthe sensors 630 for example, that the switch 614 is in the third orfourth position 618 a, 618 b.

FIG. 17 is a schematic diagram of a robotic surgical instrument 700configured to operate a surgical tool described herein according to oneaspect of this disclosure. The robotic surgical instrument 700 may beprogrammed or configured to control distal/proximal translation of adisplacement member, distal/proximal displacement of a closure tube,shaft rotation, and articulation, either with single or multiplearticulation drive links. In one aspect, the surgical instrument 700 maybe programmed or configured to individually control a firing member, aclosure member, a shaft member, and/or one or more articulation members.The surgical instrument 700 comprises a control circuit 710 configuredto control motor-driven firing members, closure members, shaft members,and/or one or more articulation members.

In one aspect, the robotic surgical instrument 700 comprises a controlcircuit 710 configured to control an anvil 716 and an I-beam 714(including a sharp cutting edge) portion of an end effector 702, aremovable staple cartridge 718, a shaft 740, and one or morearticulation members 742 a, 742 b via a plurality of motors 704 a-704 e.A position sensor 734 may be configured to provide position feedback ofthe I-beam 714 to the control circuit 710. Other sensors 738 may beconfigured to provide feedback to the control circuit 710. Atimer/counter 731 provides timing and counting information to thecontrol circuit 710. An energy source 712 may be provided to operate themotors 704 a-704 e, and a current sensor 736 provides motor currentfeedback to the control circuit 710. The motors 704 a-704 e can beoperated individually by the control circuit 710 in a open-loop orclosed-loop feedback control.

In one aspect, the control circuit 710 may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to performone or more tasks. In one aspect, a timer/counter 731 provides an outputsignal, such as the elapsed time or a digital count, to the controlcircuit 710 to correlate the position of the I-beam 714 as determined bythe position sensor 734 with the output of the timer/counter 731 suchthat the control circuit 710 can determine the position of the I-beam714 at a specific time (t) relative to a starting position or the time(t) when the I-beam 714 is at a specific position relative to a startingposition. The timer/counter 731 may be configured to measure elapsedtime, count external events, or time external events.

In one aspect, the control circuit 710 may be programmed to controlfunctions of the end effector 702 based on one or more tissueconditions. The control circuit 710 may be programmed to sense tissueconditions, such as thickness, either directly or indirectly, asdescribed herein. The control circuit 710 may be programmed to select afiring control program or closure control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 710 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 710 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power. A closure control program may control theclosure force applied to the tissue by the anvil 716. Other controlprograms control the rotation of the shaft 740 and the articulationmembers 742 a, 742 b.

In one aspect, the control circuit 710 may generate motor set pointsignals. The motor set point signals may be provided to various motorcontrollers 708 a-708 e. The motor controllers 708 a-708 e may compriseone or more circuits configured to provide motor drive signals to themotors 704 a-704 e to drive the motors 704 a-704 e as described herein.In some examples, the motors 704 a-704 e may be brushed DC electricmotors. For example, the velocity of the motors 704 a-704 e may beproportional to the respective motor drive signals. In some examples,the motors 704 a-704 e may be brushless DC electric motors, and therespective motor drive signals may comprise a PWM signal provided to oneor more stator windings of the motors 704 a-704 e. Also, in someexamples, the motor controllers 708 a-708 e may be omitted and thecontrol circuit 710 may generate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of themotors 704 a-704 e in an open-loop configuration for a first open-loopportion of a stroke of the displacement member. Based on the response ofthe robotic surgical instrument 700 during the open-loop portion of thestroke, the control circuit 710 may select a firing control program in aclosed-loop configuration. The response of the instrument may include atranslation distance of the displacement member during the open-loopportion, a time elapsed during the open-loop portion, the energyprovided to one of the motors 704 a-704 e during the open-loop portion,a sum of pulse widths of a motor drive signal, etc. After the open-loopportion, the control circuit 710 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during a closed-loop portion of the stroke, the controlcircuit 710 may modulate one of the motors 704 a-704 e based ontranslation data describing a position of the displacement member in aclosed-loop manner to translate the displacement member at a constantvelocity.

In one aspect, the motors 704 a-704 e may receive power from an energysource 712. The energy source 712 may be a DC power supply driven by amain alternating current power source, a battery, a super capacitor, orany other suitable energy source. The motors 704 a-704 e may bemechanically coupled to individual movable mechanical elements such asthe I-beam 714, anvil 716, shaft 740, articulation 742 a, andarticulation 742 b via respective transmissions 706 a-706 e. Thetransmissions 706 a-706 e may include one or more gears or other linkagecomponents to couple the motors 704 a-704 e to movable mechanicalelements. A position sensor 734 may sense a position of the I-beam 714.The position sensor 734 may be or include any type of sensor that iscapable of generating position data that indicate a position of theI-beam 714. In some examples, the position sensor 734 may include anencoder configured to provide a series of pulses to the control circuit710 as the I-beam 714 translates distally and proximally. The controlcircuit 710 may track the pulses to determine the position of the I-beam714. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 714. Also, in someexamples, the position sensor 734 may be omitted. Where any of themotors 704 a-704 e is a stepper motor, the control circuit 710 may trackthe position of the I-beam 714 by aggregating the number and directionof steps that the motor 704 has been instructed to execute. The positionsensor 734 may be located in the end effector 702 or at any otherportion of the instrument. The outputs of each of the motors 704 a-704 einclude a torque sensor 744 a-744 e to sense force and have an encoderto sense rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firingmember such as the I-beam 714 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 a,which provides a drive signal to the motor 704 a. The output shaft ofthe motor 704 a is coupled to a torque sensor 744 a. The torque sensor744 a is coupled to a transmission 706 a which is coupled to the I-beam714. The transmission 706 a comprises movable mechanical elements suchas rotating elements and a firing member to control the movement of theI-beam 714 distally and proximally along a longitudinal axis of the endeffector 702. In one aspect, the motor 704 a may be coupled to the knifegear assembly, which includes a knife gear reduction set that includes afirst knife drive gear and a second knife drive gear. A torque sensor744 a provides a firing force feedback signal to the control circuit710. The firing force signal represents the force required to fire ordisplace the I-beam 714. A position sensor 734 may be configured toprovide the position of the I-beam 714 along the firing stroke or theposition of the firing member as a feedback signal to the controlcircuit 710. The end effector 702 may include additional sensors 738configured to provide feedback signals to the control circuit 710. Whenready to use, the control circuit 710 may provide a firing signal to themotor control 708 a. In response to the firing signal, the motor 704 amay drive the firing member distally along the longitudinal axis of theend effector 702 from a proximal stroke start position to a stroke endposition distal to the stroke start position. As the firing membertranslates distally, an I-beam 714, with a cutting element positioned ata distal end, advances distally to cut tissue located between the staplecartridge 718 and the anvil 716.

In one aspect, the control circuit 710 is configured to drive a closuremember such as the anvil 716 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 b,which provides a drive signal to the motor 704 b. The output shaft ofthe motor 704 b is coupled to a torque sensor 744 b. The torque sensor744 b is coupled to a transmission 706 b which is coupled to the anvil716. The transmission 706 b comprises movable mechanical elements suchas rotating elements and a closure member to control the movement of theanvil 716 from the open and closed positions. In one aspect, the motor704 b is coupled to a closure gear assembly, which includes a closurereduction gear set that is supported in meshing engagement with theclosure spur gear. The torque sensor 744 b provides a closure forcefeedback signal to the control circuit 710. The closure force feedbacksignal represents the closure force applied to the anvil 716. Theposition sensor 734 may be configured to provide the position of theclosure member as a feedback signal to the control circuit 710.Additional sensors 738 in the end effector 702 may provide the closureforce feedback signal to the control circuit 710. The pivotable anvil716 is positioned opposite the staple cartridge 718. When ready to use,the control circuit 710 may provide a closure signal to the motorcontrol 708 b. In response to the closure signal, the motor 704 badvances a closure member to grasp tissue between the anvil 716 and thestaple cartridge 718.

In one aspect, the control circuit 710 is configured to rotate a shaftmember such as the shaft 740 to rotate the end effector 702. The controlcircuit 710 provides a motor set point to a motor control 708 c, whichprovides a drive signal to the motor 704 c. The output shaft of themotor 704 c is coupled to a torque sensor 744 c. The torque sensor 744 cis coupled to a transmission 706 c which is coupled to the shaft 740.The transmission 706 c comprises movable mechanical elements such asrotating elements to control the rotation of the shaft 740 clockwise orcounterclockwise up to and over 360°. In one aspect, the motor 704 c iscoupled to the rotational transmission assembly, which includes a tubegear segment that is formed on (or attached to) the proximal end of theproximal closure tube for operable engagement by a rotational gearassembly that is operably supported on the tool mounting plate. Thetorque sensor 744 c provides a rotation force feedback signal to thecontrol circuit 710. The rotation force feedback signal represents therotation force applied to the shaft 740. The position sensor 734 may beconfigured to provide the position of the closure member as a feedbacksignal to the control circuit 710. Additional sensors 738 such as ashaft encoder may provide the rotational position of the shaft 740 tothe control circuit 710.

In one aspect, the control circuit 710 is configured to articulate theend effector 702. The control circuit 710 provides a motor set point toa motor control 708 d, which provides a drive signal to the motor 704 d.The output shaft of the motor 704 d is coupled to a torque sensor 744 d.The torque sensor 744 d is coupled to a transmission 706 d which iscoupled to an articulation member 742 a. The transmission 706 dcomprises movable mechanical elements such as articulation elements tocontrol the articulation of the end effector 702 ±65°. In one aspect,the motor 704 d is coupled to an articulation nut, which is rotatablyjournaled on the proximal end portion of the distal spine portion and isrotatably driven thereon by an articulation gear assembly. The torquesensor 744 d provides an articulation force feedback signal to thecontrol circuit 710. The articulation force feedback signal representsthe articulation force applied to the end effector 702. Sensors 738,such as an articulation encoder, may provide the articulation positionof the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgicalsystem 700 may comprise two articulation members, or links, 742 a, 742b. These articulation members 742 a, 742 b are driven by separate diskson the robot interface (the rack) which are driven by the two motors 708d, 708 e. When the separate firing motor 704 a is provided, each ofarticulation links 742 a, 742 b can be antagonistically driven withrespect to the other link in order to provide a resistive holding motionand a load to the head when it is not moving and to provide anarticulation motion as the head is articulated. The articulation members742 a, 742 b attach to the head at a fixed radius as the head isrotated. Accordingly, the mechanical advantage of the push-and-pull linkchanges as the head is rotated. This change in the mechanical advantagemay be more pronounced with other articulation link drive systems.

In one aspect, the one or more motors 704 a-704 e may comprise a brushedDC motor with a gearbox and mechanical links to a firing member, closuremember, or articulation member. Another example includes electric motors704 a-704 e that operate the movable mechanical elements such as thedisplacement member, articulation links, closure tube, and shaft. Anoutside influence is an unmeasured, unpredictable influence of thingslike tissue, surrounding bodies, and friction on the physical system.Such outside influence can be referred to as drag, which acts inopposition to one of electric motors 704 a-704 e. The outside influence,such as drag, may cause the operation of the physical system to deviatefrom a desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolutepositioning system. In one aspect, the position sensor 734 may comprisea magnetic rotary absolute positioning system implemented as anAS5055EQFT single-chip magnetic rotary position sensor available fromAustria Microsystems, AG. The position sensor 734 may interface with thecontrol circuit 710 to provide an absolute positioning system. Theposition may include multiple Hall-effect elements located above amagnet and coupled to a CORDIC processor, also known as thedigit-by-digit method and Volder's algorithm, that is provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations.

In one aspect, the control circuit 710 may be in communication with oneor more sensors 738. The sensors 738 may be positioned on the endeffector 702 and adapted to operate with the robotic surgical instrument700 to measure the various derived parameters such as the gap distanceversus time, tissue compression versus time, and anvil strain versustime. The sensors 738 may comprise a magnetic sensor, a magnetic fieldsensor, a strain gauge, a load cell, a pressure sensor, a force sensor,a torque sensor, an inductive sensor such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor for measuring one or more parameters of the endeffector 702. The sensors 738 may include one or more sensors. Thesensors 738 may be located on the staple cartridge 718 deck to determinetissue location using segmented electrodes. The torque sensors 744 a-744e may be configured to sense force such as firing force, closure force,and/or articulation force, among others. Accordingly, the controlcircuit 710 can sense (1) the closure load experienced by the distalclosure tube and its position, (2) the firing member at the rack and itsposition, (3) what portion of the staple cartridge 718 has tissue on it,and (4) the load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise a strain gauge,such as a micro-strain gauge, configured to measure the magnitude of thestrain in the anvil 716 during a clamped condition. The strain gaugeprovides an electrical signal whose amplitude varies with the magnitudeof the strain. The sensors 738 may comprise a pressure sensor configuredto detect a pressure generated by the presence of compressed tissuebetween the anvil 716 and the staple cartridge 718. The sensors 738 maybe configured to detect impedance of a tissue section located betweenthe anvil 716 and the staple cartridge 718 that is indicative of thethickness and/or fullness of tissue located therebetween.

In one aspect, the sensors 738 may be implemented as one or more limitswitches, electromechanical devices, solid-state switches, Hall-effectdevices, magneto-resistive (MR) devices, giant magneto-resistive (GMR)devices, magnetometers, among others. In other implementations, thesensors 738 may be implemented as solid-state switches that operateunder the influence of light, such as optical sensors, IR sensors,ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors738 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the sensors 738 may be configured to measure forcesexerted on the anvil 716 by the closure drive system. For example, oneor more sensors 738 can be at an interaction point between the closuretube and the anvil 716 to detect the closure forces applied by theclosure tube to the anvil 716. The forces exerted on the anvil 716 canbe representative of the tissue compression experienced by the tissuesection captured between the anvil 716 and the staple cartridge 718. Theone or more sensors 738 can be positioned at various interaction pointsalong the closure drive system to detect the closure forces applied tothe anvil 716 by the closure drive system. The one or more sensors 738may be sampled in real time during a clamping operation by the processorof the control circuit 710. The control circuit 710 receives real-timesample measurements to provide and analyze time-based information andassess, in real time, closure forces applied to the anvil 716.

In one aspect, a current sensor 736 can be employed to measure thecurrent drawn by each of the motors 704 a-704 e. The force required toadvance any of the movable mechanical elements such as the I-beam 714corresponds to the current drawn by one of the motors 704 a-704 e. Theforce is converted to a digital signal and provided to the controlcircuit 710. The control circuit 710 can be configured to simulate theresponse of the actual system of the instrument in the software of thecontroller. A displacement member can be actuated to move an I-beam 714in the end effector 702 at or near a target velocity. The roboticsurgical instrument 700 can include a feedback controller, which can beone of any feedback controllers, including, but not limited to a PID, astate feedback, a linear-quadratic (LQR), and/or an adaptive controller,for example. The robotic surgical instrument 700 can include a powersource to convert the signal from the feedback controller into aphysical input such as case voltage, PWM voltage, frequency modulatedvoltage, current, torque, and/or force, for example. Additional detailsare disclosed in U.S. patent application Ser. No. 15/636,829, titledCLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT,filed Jun. 29, 2017, which is herein incorporated by reference in itsentirety.

FIG. 18 illustrates a block diagram of a surgical instrument 750programmed to control the distal translation of a displacement memberaccording to one aspect of this disclosure. In one aspect, the surgicalinstrument 750 is programmed to control the distal translation of adisplacement member such as the I-beam 764. The surgical instrument 750comprises an end effector 752 that may comprise an anvil 766, an I-beam764 (including a sharp cutting edge), and a removable staple cartridge768.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensor784. Because the I-beam 764 is coupled to a longitudinally movable drivemember, the position of the I-beam 764 can be determined by measuringthe position of the longitudinally movable drive member employing theposition sensor 784. Accordingly, in the following description, theposition, displacement, and/or translation of the I-beam 764 can beachieved by the position sensor 784 as described herein. A controlcircuit 760 may be programmed to control the translation of thedisplacement member, such as the I-beam 764. The control circuit 760, insome examples, may comprise one or more microcontrollers,microprocessors, or other suitable processors for executing instructionsthat cause the processor or processors to control the displacementmember, e.g., the I-beam 764, in the manner described. In one aspect, atimer/counter 781 provides an output signal, such as the elapsed time ora digital count, to the control circuit 760 to correlate the position ofthe I-beam 764 as determined by the position sensor 784 with the outputof the timer/counter 781 such that the control circuit 760 can determinethe position of the I-beam 764 at a specific time (t) relative to astarting position. The timer/counter 781 may be configured to measureelapsed time, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor 754 has been instructed to execute. The position sensor 784 may belocated in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by a closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor of the control circuit760. The control circuit 760 receives real-time sample measurements toprovide and analyze time-based information and assess, in real time,closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move an I-beam 764 in the endeffector 752 at or near a target velocity. The surgical instrument 750can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or I-beam 764, by abrushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical stapling andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable anvil 766and, when configured for use, a staple cartridge 768 positioned oppositethe anvil 766. A clinician may grasp tissue between the anvil 766 andthe staple cartridge 768, as described herein. When ready to use theinstrument 750, the clinician may provide a firing signal, for exampleby depressing a trigger of the instrument 750. In response to the firingsignal, the motor 754 may drive the displacement member distally alongthe longitudinal axis of the end effector 752 from a proximal strokebegin position to a stroke end position distal of the stroke beginposition. As the displacement member translates distally, an I-beam 764with a cutting element positioned at a distal end, may cut the tissuebetween the staple cartridge 768 and the anvil 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the I-beam 764, for example, based on oneor more tissue conditions. The control circuit 760 may be programmed tosense tissue conditions, such as thickness, either directly orindirectly, as described herein. The control circuit 760 may beprogrammed to select a firing control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 760 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of theinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. patent application Ser. No. 15/720,852,titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICALINSTRUMENT, filed Sep. 29, 2017, which is herein incorporated byreference in its entirety.

FIG. 19 is a schematic diagram of a surgical instrument 790 configuredto control various functions according to one aspect of this disclosure.In one aspect, the surgical instrument 790 is programmed to controldistal translation of a displacement member such as the I-beam 764. Thesurgical instrument 790 comprises an end effector 792 that may comprisean anvil 766, an I-beam 764, and a removable staple cartridge 768 whichmay be interchanged with an RF cartridge 796 (shown in dashed line).

In one aspect, sensors 788 may be implemented as a limit switch,electromechanical device, solid-state switches, Hall-effect devices, MRdevices, GMR devices, magnetometers, among others. In otherimplementations, the sensors 638 may be solid-state switches thatoperate under the influence of light, such as optical sensors, IRsensors, ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors788 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolutepositioning system comprising a magnetic rotary absolute positioningsystem implemented as an AS5055EQFT single-chip magnetic rotary positionsensor available from Austria Microsystems, AG. The position sensor 784may interface with the control circuit 760 to provide an absolutepositioning system. The position may include multiple Hall-effectelements located above a magnet and coupled to a CORDIC processor, alsoknown as the digit-by-digit method and Volder's algorithm, that isprovided to implement a simple and efficient algorithm to calculatehyperbolic and trigonometric functions that require only addition,subtraction, bitshift, and table lookup operations.

In one aspect, the I-beam 764 may be implemented as a knife membercomprising a knife body that operably supports a tissue cutting bladethereon and may further include anvil engagement tabs or features andchannel engagement features or a foot. In one aspect, the staplecartridge 768 may be implemented as a standard (mechanical) surgicalfastener cartridge. In one aspect, the RF cartridge 796 may beimplemented as an RF cartridge. These and other sensors arrangements aredescribed in commonly-owned U.S. patent application Ser. No. 15/628,175,titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICALSTAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, which is hereinincorporated by reference in its entirety.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensorrepresented as position sensor 784. Because the I-beam 764 is coupled tothe longitudinally movable drive member, the position of the I-beam 764can be determined by measuring the position of the longitudinallymovable drive member employing the position sensor 784. Accordingly, inthe following description, the position, displacement, and/ortranslation of the I-beam 764 can be achieved by the position sensor 784as described herein. A control circuit 760 may be programmed to controlthe translation of the displacement member, such as the I-beam 764, asdescribed herein. The control circuit 760, in some examples, maycomprise one or more microcontrollers, microprocessors, or othersuitable processors for executing instructions that cause the processoror processors to control the displacement member, e.g., the I-beam 764,in the manner described. In one aspect, a timer/counter 781 provides anoutput signal, such as the elapsed time or a digital count, to thecontrol circuit 760 to correlate the position of the I-beam 764 asdetermined by the position sensor 784 with the output of thetimer/counter 781 such that the control circuit 760 can determine theposition of the I-beam 764 at a specific time (t) relative to a startingposition. The timer/counter 781 may be configured to measure elapsedtime, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor has been instructed to execute. The position sensor 784 may belocated in the end effector 792 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 792 andadapted to operate with the surgical instrument 790 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 792. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by the closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor portion of the controlcircuit 760. The control circuit 760 receives real-time samplemeasurements to provide and analyze time-based information and assess,in real time, closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

An RF energy source 794 is coupled to the end effector 792 and isapplied to the RF cartridge 796 when the RF cartridge 796 is loaded inthe end effector 792 in place of the staple cartridge 768. The controlcircuit 760 controls the delivery of the RF energy to the RF cartridge796.

Additional details are disclosed in U.S. patent application Ser. No.15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE ANDRADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed Jun. 28,2017, which is herein incorporated by reference in its entirety.

Generator Hardware

FIG. 20 is a simplified block diagram of a generator 800 configured toprovide inductorless tuning, among other benefits. Additional details ofthe generator 800 are described in U.S. Pat. No. 9,060,775, titledSURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, whichissued on Jun. 23, 2015, which is herein incorporated by reference inits entirety. The generator 800 may comprise a patient isolated stage802 in communication with a non-isolated stage 804 via a powertransformer 806. A secondary winding 808 of the power transformer 806 iscontained in the isolated stage 802 and may comprise a tappedconfiguration (e.g., a center-tapped or a non-center-tappedconfiguration) to define drive signal outputs 810 a, 810 b, 810 c fordelivering drive signals to different surgical instruments, such as, forexample, an ultrasonic surgical instrument, an RF electrosurgicalinstrument, and a multifunction surgical instrument which includesultrasonic and RF energy modes that can be delivered alone orsimultaneously. In particular, drive signal outputs 810 a, 810 c mayoutput an ultrasonic drive signal (e.g., a 420V root-mean-square (RMS)drive signal) to an ultrasonic surgical instrument, and drive signaloutputs 810 b, 810 c may output an RF electrosurgical drive signal(e.g., a 100V RMS drive signal) to an RF electrosurgical instrument,with the drive signal output 810 b corresponding to the center tap ofthe power transformer 806.

In certain forms, the ultrasonic and electrosurgical drive signals maybe provided simultaneously to distinct surgical instruments and/or to asingle surgical instrument, such as the multifunction surgicalinstrument, having the capability to deliver both ultrasonic andelectrosurgical energy to tissue. It will be appreciated that theelectrosurgical signal, provided either to a dedicated electrosurgicalinstrument and/or to a combined multifunction ultrasonic/electrosurgicalinstrument may be either a therapeutic or sub-therapeutic level signalwhere the sub-therapeutic signal can be used, for example, to monitortissue or instrument conditions and provide feedback to the generator.For example, the ultrasonic and RF signals can be delivered separatelyor simultaneously from a generator with a single output port in order toprovide the desired output signal to the surgical instrument, as will bediscussed in more detail below. Accordingly, the generator can combinethe ultrasonic and electrosurgical RF energies and deliver the combinedenergies to the multifunction ultrasonic/electrosurgical instrument.Bipolar electrodes can be placed on one or both jaws of the endeffector. One jaw may be driven by ultrasonic energy in addition toelectrosurgical RF energy, working simultaneously. The ultrasonic energymay be employed to dissect tissue, while the electrosurgical RF energymay be employed for vessel sealing.

The non-isolated stage 804 may comprise a power amplifier 812 having anoutput connected to a primary winding 814 of the power transformer 806.In certain forms, the power amplifier 812 may comprise a push-pullamplifier. For example, the non-isolated stage 804 may further comprisea logic device 816 for supplying a digital output to a digital-to-analogconverter (DAC) circuit 818, which in turn supplies a correspondinganalog signal to an input of the power amplifier 812. In certain forms,the logic device 816 may comprise a programmable gate array (PGA), aFPGA, programmable logic device (PLD), among other logic circuits, forexample. The logic device 816, by virtue of controlling the input of thepower amplifier 812 via the DAC circuit 818, may therefore control anyof a number of parameters (e.g., frequency, waveform shape, waveformamplitude) of drive signals appearing at the drive signal outputs 810 a,810 b, 810 c. In certain forms and as discussed below, the logic device816, in conjunction with a processor (e.g., a DSP discussed below), mayimplement a number of DSP-based and/or other control algorithms tocontrol parameters of the drive signals output by the generator 800.

Power may be supplied to a power rail of the power amplifier 812 by aswitch-mode regulator 820, e.g., a power converter. In certain forms,the switch-mode regulator 820 may comprise an adjustable buck regulator,for example. The non-isolated stage 804 may further comprise a firstprocessor 822, which in one form may comprise a DSP processor such as anAnalog Devices ADSP-21469 SHARC DSP, available from Analog Devices,Norwood, MA, for example, although in various forms any suitableprocessor may be employed. In certain forms the DSP processor 822 maycontrol the operation of the switch-mode regulator 820 responsive tovoltage feedback data received from the power amplifier 812 by the DSPprocessor 822 via an ADC circuit 824. In one form, for example, the DSPprocessor 822 may receive as input, via the ADC circuit 824, thewaveform envelope of a signal (e.g., an RF signal) being amplified bythe power amplifier 812. The DSP processor 822 may then control theswitch-mode regulator 820 (e.g., via a PWM output) such that the railvoltage supplied to the power amplifier 812 tracks the waveform envelopeof the amplified signal. By dynamically modulating the rail voltage ofthe power amplifier 812 based on the waveform envelope, the efficiencyof the power amplifier 812 may be significantly improved relative to afixed rail voltage amplifier schemes.

In certain forms, the logic device 816, in conjunction with the DSPprocessor 822, may implement a digital synthesis circuit such as adirect digital synthesizer control scheme to control the waveform shape,frequency, and/or amplitude of drive signals output by the generator800. In one form, for example, the logic device 816 may implement a DDScontrol algorithm by recalling waveform samples stored in a dynamicallyupdated lookup table (LUT), such as a RAM LUT, which may be embedded inan FPGA. This control algorithm is particularly useful for ultrasonicapplications in which an ultrasonic transducer, such as an ultrasonictransducer, may be driven by a clean sinusoidal current at its resonantfrequency. Because other frequencies may excite parasitic resonances,minimizing or reducing the total distortion of the motional branchcurrent may correspondingly minimize or reduce undesirable resonanceeffects. Because the waveform shape of a drive signal output by thegenerator 800 is impacted by various sources of distortion present inthe output drive circuit (e.g., the power transformer 806, the poweramplifier 812), voltage and current feedback data based on the drivesignal may be input into an algorithm, such as an error controlalgorithm implemented by the DSP processor 822, which compensates fordistortion by suitably pre-distorting or modifying the waveform samplesstored in the LUT on a dynamic, ongoing basis (e.g., in real time). Inone form, the amount or degree of pre-distortion applied to the LUTsamples may be based on the error between a computed motional branchcurrent and a desired current waveform shape, with the error beingdetermined on a sample-by-sample basis. In this way, the pre-distortedLUT samples, when processed through the drive circuit, may result in amotional branch drive signal having the desired waveform shape (e.g.,sinusoidal) for optimally driving the ultrasonic transducer. In suchforms, the LUT waveform samples will therefore not represent the desiredwaveform shape of the drive signal, but rather the waveform shape thatis required to ultimately produce the desired waveform shape of themotional branch drive signal when distortion effects are taken intoaccount.

The non-isolated stage 804 may further comprise a first ADC circuit 826and a second ADC circuit 828 coupled to the output of the powertransformer 806 via respective isolation transformers 830, 832 forrespectively sampling the voltage and current of drive signals output bythe generator 800. In certain forms, the ADC circuits 826, 828 may beconfigured to sample at high speeds (e.g., 80 mega samples per second(MSPS)) to enable oversampling of the drive signals. In one form, forexample, the sampling speed of the ADC circuits 826, 828 may enableapproximately 200× (depending on frequency) oversampling of the drivesignals. In certain forms, the sampling operations of the ADC circuit826, 828 may be performed by a single ADC circuit receiving inputvoltage and current signals via a two-way multiplexer. The use ofhigh-speed sampling in forms of the generator 800 may enable, amongother things, calculation of the complex current flowing through themotional branch (which may be used in certain forms to implementDDS-based waveform shape control described above), accurate digitalfiltering of the sampled signals, and calculation of real powerconsumption with a high degree of precision. Voltage and currentfeedback data output by the ADC circuits 826, 828 may be received andprocessed (e.g., first-in-first-out (FIFO) buffer, multiplexer) by thelogic device 816 and stored in data memory for subsequent retrieval by,for example, the DSP processor 822. As noted above, voltage and currentfeedback data may be used as input to an algorithm for pre-distorting ormodifying LUT waveform samples on a dynamic and ongoing basis. Incertain forms, this may require each stored voltage and current feedbackdata pair to be indexed based on, or otherwise associated with, acorresponding LUT sample that was output by the logic device 816 whenthe voltage and current feedback data pair was acquired. Synchronizationof the LUT samples and the voltage and current feedback data in thismanner contributes to the correct timing and stability of thepre-distortion algorithm.

In certain forms, the voltage and current feedback data may be used tocontrol the frequency and/or amplitude (e.g., current amplitude) of thedrive signals. In one form, for example, voltage and current feedbackdata may be used to determine impedance phase. The frequency of thedrive signal may then be controlled to minimize or reduce the differencebetween the determined impedance phase and an impedance phase setpoint(e.g., 0°), thereby minimizing or reducing the effects of harmonicdistortion and correspondingly enhancing impedance phase measurementaccuracy. The determination of phase impedance and a frequency controlsignal may be implemented in the DSP processor 822, for example, withthe frequency control signal being supplied as input to a DDS controlalgorithm implemented by the logic device 816.

In another form, for example, the current feedback data may be monitoredin order to maintain the current amplitude of the drive signal at acurrent amplitude setpoint. The current amplitude setpoint may bespecified directly or determined indirectly based on specified voltageamplitude and power setpoints. In certain forms, control of the currentamplitude may be implemented by control algorithm, such as, for example,a proportional-integral-derivative (PID) control algorithm, in the DSPprocessor 822. Variables controlled by the control algorithm to suitablycontrol the current amplitude of the drive signal may include, forexample, the scaling of the LUT waveform samples stored in the logicdevice 816 and/or the full-scale output voltage of the DAC circuit 818(which supplies the input to the power amplifier 812) via a DAC circuit834.

The non-isolated stage 804 may further comprise a second processor 836for providing, among other things user interface (UI) functionality. Inone form, the UI processor 836 may comprise an Atmel AT91SAM9263processor having an ARM 926EJ-S core, available from Atmel Corporation,San Jose, California, for example. Examples of UI functionalitysupported by the UI processor 836 may include audible and visual userfeedback, communication with peripheral devices (e.g., via a USBinterface), communication with a foot switch, communication with aninput device (e.g., a touch screen display) and communication with anoutput device (e.g., a speaker). The UI processor 836 may communicatewith the DSP processor 822 and the logic device 816 (e.g., via SPIbuses). Although the UI processor 836 may primarily support UIfunctionality, it may also coordinate with the DSP processor 822 toimplement hazard mitigation in certain forms. For example, the UIprocessor 836 may be programmed to monitor various aspects of user inputand/or other inputs (e.g., touch screen inputs, foot switch inputs,temperature sensor inputs) and may disable the drive output of thegenerator 800 when an erroneous condition is detected.

In certain forms, both the DSP processor 822 and the UI processor 836,for example, may determine and monitor the operating state of thegenerator 800. For the DSP processor 822, the operating state of thegenerator 800 may dictate, for example, which control and/or diagnosticprocesses are implemented by the DSP processor 822. For the UI processor836, the operating state of the generator 800 may dictate, for example,which elements of a UI (e.g., display screens, sounds) are presented toa user. The respective DSP and UI processors 822, 836 may independentlymaintain the current operating state of the generator 800 and recognizeand evaluate possible transitions out of the current operating state.The DSP processor 822 may function as the master in this relationshipand determine when transitions between operating states are to occur.The UI processor 836 may be aware of valid transitions between operatingstates and may confirm if a particular transition is appropriate. Forexample, when the DSP processor 822 instructs the UI processor 836 totransition to a specific state, the UI processor 836 may verify thatrequested transition is valid. In the event that a requested transitionbetween states is determined to be invalid by the UI processor 836, theUI processor 836 may cause the generator 800 to enter a failure mode.

The non-isolated stage 804 may further comprise a controller 838 formonitoring input devices (e.g., a capacitive touch sensor used forturning the generator 800 on and off, a capacitive touch screen). Incertain forms, the controller 838 may comprise at least one processorand/or other controller device in communication with the UI processor836. In one form, for example, the controller 838 may comprise aprocessor (e.g., a Meg168 8-bit controller available from Atmel)configured to monitor user input provided via one or more capacitivetouch sensors. In one form, the controller 838 may comprise a touchscreen controller (e.g., a QT5480 touch screen controller available fromAtmel) to control and manage the acquisition of touch data from acapacitive touch screen.

In certain forms, when the generator 800 is in a “power off” state, thecontroller 838 may continue to receive operating power (e.g., via a linefrom a power supply of the generator 800, such as the power supply 854discussed below). In this way, the controller 838 may continue tomonitor an input device (e.g., a capacitive touch sensor located on afront panel of the generator 800) for turning the generator 800 on andoff. When the generator 800 is in the power off state, the controller838 may wake the power supply (e.g., enable operation of one or moreDC/DC voltage converters 856 of the power supply 854) if activation ofthe “on/off” input device by a user is detected. The controller 838 maytherefore initiate a sequence for transitioning the generator 800 to a“power on” state. Conversely, the controller 838 may initiate a sequencefor transitioning the generator 800 to the power off state if activationof the “on/off” input device is detected when the generator 800 is inthe power on state. In certain forms, for example, the controller 838may report activation of the “on/off” input device to the UI processor836, which in turn implements the necessary process sequence fortransitioning the generator 800 to the power off state. In such forms,the controller 838 may have no independent ability for causing theremoval of power from the generator 800 after its power on state hasbeen established.

In certain forms, the controller 838 may cause the generator 800 toprovide audible or other sensory feedback for alerting the user that apower on or power off sequence has been initiated. Such an alert may beprovided at the beginning of a power on or power off sequence and priorto the commencement of other processes associated with the sequence.

In certain forms, the isolated stage 802 may comprise an instrumentinterface circuit 840 to, for example, provide a communication interfacebetween a control circuit of a surgical instrument (e.g., a controlcircuit comprising handpiece switches) and components of thenon-isolated stage 804, such as, for example, the logic device 816, theDSP processor 822, and/or the UI processor 836. The instrument interfacecircuit 840 may exchange information with components of the non-isolatedstage 804 via a communication link that maintains a suitable degree ofelectrical isolation between the isolated and non-isolated stages 802,804, such as, for example, an IR-based communication link. Power may besupplied to the instrument interface circuit 840 using, for example, alow-dropout voltage regulator powered by an isolation transformer drivenfrom the non-isolated stage 804.

In one form, the instrument interface circuit 840 may comprise a logiccircuit 842 (e.g., logic circuit, programmable logic circuit, PGA, FPGA,PLD) in communication with a signal conditioning circuit 844. The signalconditioning circuit 844 may be configured to receive a periodic signalfrom the logic circuit 842 (e.g., a 2 kHz square wave) to generate abipolar interrogation signal having an identical frequency. Theinterrogation signal may be generated, for example, using a bipolarcurrent source fed by a differential amplifier. The interrogation signalmay be communicated to a surgical instrument control circuit (e.g., byusing a conductive pair in a cable that connects the generator 800 tothe surgical instrument) and monitored to determine a state orconfiguration of the control circuit. The control circuit may comprise anumber of switches, resistors, and/or diodes to modify one or morecharacteristics (e.g., amplitude, rectification) of the interrogationsignal such that a state or configuration of the control circuit isuniquely discernable based on the one or more characteristics. In oneform, for example, the signal conditioning circuit 844 may comprise anADC circuit for generating samples of a voltage signal appearing acrossinputs of the control circuit resulting from passage of interrogationsignal therethrough. The logic circuit 842 (or a component of thenon-isolated stage 804) may then determine the state or configuration ofthe control circuit based on the ADC circuit samples.

In one form, the instrument interface circuit 840 may comprise a firstdata circuit interface 846 to enable information exchange between thelogic circuit 842 (or other element of the instrument interface circuit840) and a first data circuit disposed in or otherwise associated with asurgical instrument. In certain forms, for example, a first data circuitmay be disposed in a cable integrally attached to a surgical instrumenthandpiece or in an adaptor for interfacing a specific surgicalinstrument type or model with the generator 800. The first data circuitmay be implemented in any suitable manner and may communicate with thegenerator according to any suitable protocol, including, for example, asdescribed herein with respect to the first data circuit. In certainforms, the first data circuit may comprise a non-volatile storagedevice, such as an EEPROM device. In certain forms, the first datacircuit interface 846 may be implemented separately from the logiccircuit 842 and comprise suitable circuitry (e.g., discrete logicdevices, a processor) to enable communication between the logic circuit842 and the first data circuit. In other forms, the first data circuitinterface 846 may be integral with the logic circuit 842.

In certain forms, the first data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information. This informationmay be read by the instrument interface circuit 840 (e.g., by the logiccircuit 842), transferred to a component of the non-isolated stage 804(e.g., to logic device 816, DSP processor 822, and/or UI processor 836)for presentation to a user via an output device and/or for controlling afunction or operation of the generator 800. Additionally, any type ofinformation may be communicated to the first data circuit for storagetherein via the first data circuit interface 846 (e.g., using the logiccircuit 842). Such information may comprise, for example, an updatednumber of operations in which the surgical instrument has been usedand/or dates and/or times of its usage.

As discussed previously, a surgical instrument may be detachable from ahandpiece (e.g., the multifunction surgical instrument may be detachablefrom the handpiece) to promote instrument interchangeability and/ordisposability. In such cases, conventional generators may be limited intheir ability to recognize particular instrument configurations beingused and to optimize control and diagnostic processes accordingly. Theaddition of readable data circuits to surgical instruments to addressthis issue is problematic from a compatibility standpoint, however. Forexample, designing a surgical instrument to remain backwardly compatiblewith generators that lack the requisite data reading functionality maybe impractical due to, for example, differing signal schemes, designcomplexity, and cost. Forms of instruments discussed herein addressthese concerns by using data circuits that may be implemented inexisting surgical instruments economically and with minimal designchanges to preserve compatibility of the surgical instruments withcurrent generator platforms.

Additionally, forms of the generator 800 may enable communication withinstrument-based data circuits. For example, the generator 800 may beconfigured to communicate with a second data circuit contained in aninstrument (e.g., the multifunction surgical instrument). In some forms,the second data circuit may be implemented in a many similar to that ofthe first data circuit described herein. The instrument interfacecircuit 840 may comprise a second data circuit interface 848 to enablethis communication. In one form, the second data circuit interface 848may comprise a tri-state digital interface, although other interfacesmay also be used. In certain forms, the second data circuit maygenerally be any circuit for transmitting and/or receiving data. In oneform, for example, the second data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information.

In some forms, the second data circuit may store information about theelectrical and/or ultrasonic properties of an associated ultrasonictransducer, end effector, or ultrasonic drive system. For example, thefirst data circuit may indicate a burn-in frequency slope, as describedherein. Additionally or alternatively, any type of information may becommunicated to second data circuit for storage therein via the seconddata circuit interface 848 (e.g., using the logic circuit 842). Suchinformation may comprise, for example, an updated number of operationsin which the instrument has been used and/or dates and/or times of itsusage. In certain forms, the second data circuit may transmit dataacquired by one or more sensors (e.g., an instrument-based temperaturesensor). In certain forms, the second data circuit may receive data fromthe generator 800 and provide an indication to a user (e.g., a lightemitting diode indication or other visible indication) based on thereceived data.

In certain forms, the second data circuit and the second data circuitinterface 848 may be configured such that communication between thelogic circuit 842 and the second data circuit can be effected withoutthe need to provide additional conductors for this purpose (e.g.,dedicated conductors of a cable connecting a handpiece to the generator800). In one form, for example, information may be communicated to andfrom the second data circuit using a one-wire bus communication schemeimplemented on existing cabling, such as one of the conductors usedtransmit interrogation signals from the signal conditioning circuit 844to a control circuit in a handpiece. In this way, design changes ormodifications to the surgical instrument that might otherwise benecessary are minimized or reduced. Moreover, because different types ofcommunications implemented over a common physical channel can befrequency-band separated, the presence of a second data circuit may be“invisible” to generators that do not have the requisite data readingfunctionality, thus enabling backward compatibility of the surgicalinstrument.

In certain forms, the isolated stage 802 may comprise at least oneblocking capacitor 850-1 connected to the drive signal output 810 b toprevent passage of DC current to a patient. A single blocking capacitormay be required to comply with medical regulations or standards, forexample. While failure in single-capacitor designs is relativelyuncommon, such failure may nonetheless have negative consequences. Inone form, a second blocking capacitor 850-2 may be provided in serieswith the blocking capacitor 850-1, with current leakage from a pointbetween the blocking capacitors 850-1, 850-2 being monitored by, forexample, an ADC circuit 852 for sampling a voltage induced by leakagecurrent. The samples may be received by the logic circuit 842, forexample. Based changes in the leakage current (as indicated by thevoltage samples), the generator 800 may determine when at least one ofthe blocking capacitors 850-1, 850-2 has failed, thus providing abenefit over single-capacitor designs having a single point of failure.

In certain forms, the non-isolated stage 804 may comprise a power supply854 for delivering DC power at a suitable voltage and current. The powersupply may comprise, for example, a 400 W power supply for delivering a48 VDC system voltage. The power supply 854 may further comprise one ormore DC/DC voltage converters 856 for receiving the output of the powersupply to generate DC outputs at the voltages and currents required bythe various components of the generator 800. As discussed above inconnection with the controller 838, one or more of the DC/DC voltageconverters 856 may receive an input from the controller 838 whenactivation of the “on/off” input device by a user is detected by thecontroller 838 to enable operation of, or wake, the DC/DC voltageconverters 856.

FIG. 21 illustrates an example of a generator 900, which is one form ofthe generator 800 (FIG. 20 ). The generator 900 is configured to delivermultiple energy modalities to a surgical instrument. The generator 900provides RF and ultrasonic signals for delivering energy to a surgicalinstrument either independently or simultaneously. The RF and ultrasonicsignals may be provided alone or in combination and may be providedsimultaneously. As noted above, at least one generator output candeliver multiple energy modalities (e.g., ultrasonic, bipolar ormonopolar RF, irreversible and/or reversible electroporation, and/ormicrowave energy, among others) through a single port, and these signalscan be delivered separately or simultaneously to the end effector totreat tissue.

The generator 900 comprises a processor 902 coupled to a waveformgenerator 904. The processor 902 and waveform generator 904 areconfigured to generate a variety of signal waveforms based oninformation stored in a memory coupled to the processor 902, not shownfor clarity of disclosure. The digital information associated with awaveform is provided to the waveform generator 904 which includes one ormore DAC circuits to convert the digital input into an analog output.The analog output is fed to an amplifier 1106 for signal conditioningand amplification. The conditioned and amplified output of the amplifier906 is coupled to a power transformer 908. The signals are coupledacross the power transformer 908 to the secondary side, which is in thepatient isolation side. A first signal of a first energy modality isprovided to the surgical instrument between the terminals labeledENERGY1 and RETURN. A second signal of a second energy modality iscoupled across a capacitor 910 and is provided to the surgicalinstrument between the terminals labeled ENERGY2 and RETURN. It will beappreciated that more than two energy modalities may be output and thusthe subscript “n” may be used to designate that up to n ENERGYnterminals may be provided, where n is a positive integer greater than 1.It also will be appreciated that up to “n” return paths RETURNn may beprovided without departing from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across the terminalslabeled ENERGY1 and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 924 is coupled across theterminals labeled ENERGY2 and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 914 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 908 as shown to measure the output current for either energymodality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to respective isolation transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 918. The outputs of the isolationtransformers 916, 928, 922 in the on the primary side of the powertransformer 908 (non-patient isolated side) are provided to a one ormore ADC circuit 926. The digitized output of the ADC circuit 926 isprovided to the processor 902 for further processing and computation.The output voltages and output current feedback information can beemployed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters. Input/output communications between the processor 902 andpatient isolated circuits is provided through an interface circuit 920.Sensors also may be in electrical communication with the processor 902by way of the interface circuit 920.

In one aspect, the impedance may be determined by the processor 902 bydividing the output of either the first voltage sensing circuit 912coupled across the terminals labeled ENERGY1/RETURN or the secondvoltage sensing circuit 924 coupled across the terminals labeledENERGY2/RETURN by the output of the current sensing circuit 914 disposedin series with the RETURN leg of the secondary side of the powertransformer 908. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to separate isolations transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 916. The digitized voltage and currentsensing measurements from the ADC circuit 926 are provided the processor902 for computing impedance. As an example, the first energy modalityENERGY1 may be ultrasonic energy and the second energy modality ENERGY2may be RF energy. Nevertheless, in addition to ultrasonic and bipolar ormonopolar RF energy modalities, other energy modalities includeirreversible and/or reversible electroporation and/or microwave energy,among others. Also, although the example illustrated in FIG. 21 shows asingle return path RETURN may be provided for two or more energymodalities, in other aspects, multiple return paths RETURNn may beprovided for each energy modality ENERGYn. Thus, as described herein,the ultrasonic transducer impedance may be measured by dividing theoutput of the first voltage sensing circuit 912 by the current sensingcircuit 914 and the tissue impedance may be measured by dividing theoutput of the second voltage sensing circuit 924 by the current sensingcircuit 914.

As shown in FIG. 21 , the generator 900 comprising at least one outputport can include a power transformer 908 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 900 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 900 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 900 output would be preferably located between the outputlabeled ENERGY1 and RETURN as shown in FIG. 21 . In one example, aconnection of RF bipolar electrodes to the generator 900 output would bepreferably located between the output labeled ENERGY2 and RETURN. In thecase of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other probe) to the ENERGY2 output and asuitable return pad connected to the RETURN output.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which published on Mar. 30, 2017, which is hereinincorporated by reference in its entirety.

As used throughout this description, the term “wireless” and itsderivatives may be used to describe circuits, devices, systems, methods,techniques, communications channels, etc., that may communicate datathrough the use of modulated electromagnetic radiation through anon-solid medium. The term does not imply that the associated devices donot contain any wires, although in some aspects they might not. Thecommunication module may implement any of a number of wireless or wiredcommunication standards or protocols, including but not limited to W-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long termevolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA,TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as anyother wireless and wired protocols that are designated as 3G, 4G, 5G,and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter range wireless communications such as Wi-Fi andBluetooth and a second communication module may be dedicated to longerrange wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE,Ev-DO, and others.

As used herein a processor or processing unit is an electronic circuitwhich performs operations on some external data source, usually memoryor some other data stream. The term is used herein to refer to thecentral processor (central processing unit) in a system or computersystems (especially systems on a chip (SoCs)) that combine a number ofspecialized “processors.”

As used herein, a system on a chip or system on chip (SoC or SOC) is anintegrated circuit (also known as an “IC” or “chip”) that integrates allcomponents of a computer or other electronic systems. It may containdigital, analog, mixed-signal, and often radio-frequency functions—allon a single substrate. A SoC integrates a microcontroller (ormicroprocessor) with advanced peripherals like graphics processing unit(GPU), W-Fi module, or coprocessor. A SoC may or may not containbuilt-in memory.

As used herein, a microcontroller or controller is a system thatintegrates a microprocessor with peripheral circuits and memory. Amicrocontroller (or MCU for microcontroller unit) may be implemented asa small computer on a single integrated circuit. It may be similar to aSoC; an SoC may include a microcontroller as one of its components. Amicrocontroller may contain one or more core processing units (CPUs)along with memory and programmable input/output peripherals. Programmemory in the form of Ferroelectric RAM, NOR flash or OTP ROM is alsooften included on chip, as well as a small amount of RAM.Microcontrollers may be employed for embedded applications, in contrastto the microprocessors used in personal computers or other generalpurpose applications consisting of various discrete chips.

As used herein, the term controller or microcontroller may be astand-alone IC or chip device that interfaces with a peripheral device.This may be a link between two parts of a computer or a controller on anexternal device that manages the operation of (and connection with) thatdevice.

Any of the processors or microcontrollers described herein, may beimplemented by any single core or multicore processor such as thoseknown under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising on-chipmemory of 256 KB single-cycle flash memory, or other non-volatilememory, up to 40 MHz, a prefetch buffer to improve performance above 40MHz, a 32 KB single-cycle serial random access memory (SRAM), internalread-only memory (ROM) loaded with StellarisWare® software, 2 KBelectrically erasable programmable read-only memory (EEPROM), one ormore pulse width modulation (PWM) modules, one or more quadratureencoder inputs (QEI) analog, one or more 12-bit Analog-to-DigitalConverters (ADC) with 12 analog input channels, details of which areavailable for the product datasheet.

In one aspect, the processor may comprise a safety controller comprisingtwo controller-based families such as TMS570 and RM4× known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

Modular devices include the modules (as described in connection withFIGS. 3 and 9 , for example) that are receivable within a surgical huband the surgical devices or instruments that can be connected to thevarious modules in order to connect or pair with the correspondingsurgical hub. The modular devices include, for example, intelligentsurgical instruments, medical imaging devices, suction/irrigationdevices, smoke evacuators, energy generators, ventilators, insufflators,and displays. The modular devices described herein can be controlled bycontrol algorithms. The control algorithms can be executed on themodular device itself, on the surgical hub to which the particularmodular device is paired, or on both the modular device and the surgicalhub (e.g., via a distributed computing architecture). In someexemplifications, the modular devices' control algorithms control thedevices based on data sensed by the modular device itself (i.e., bysensors in, on, or connected to the modular device). This data can berelated to the patient being operated on (e.g., tissue properties orinsufflation pressure) or the modular device itself (e.g., the rate atwhich a knife is being advanced, motor current, or energy levels). Forexample, a control algorithm for a surgical stapling and cuttinginstrument can control the rate at which the instrument's motor drivesits knife through tissue according to resistance encountered by theknife as it advances.

Visualization System

During a surgical procedure, a surgeon may be required to manipulatetissues to effect a desired medical outcome. The actions of the surgeonare limited by what is visually observable in the surgical site. Thus,the surgeon may not be aware, for example, of the disposition ofvascular structures that underlie the tissues being manipulated duringthe procedure. Since the surgeon is unable to visualize the vasculaturebeneath a surgical site, the surgeon may accidentally sever one or morecritical blood vessels during the procedure. The solution is a surgicalvisualization system that can acquire imaging data of the surgical sitefor presentation to a surgeon, in which the presentation can includeinformation related to the presence and depth of vascular structureslocated beneath the surface of a surgical site.

In one aspect, the surgical hub 106 incorporates a visualization system108 to acquire imaging data during a surgical procedure. Thevisualization system 108 may include one or more illumination sourcesand one or more light sensors. The one or more illumination sources andone or more light sensors may be incorporated together into a singledevice or may comprise one or more separate devices. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more light sensors may receive lightreflected or refracted from the surgical field including light reflectedor refracted from tissue and/or surgical instruments. The followingdescription includes all of the hardware and software processingtechniques disclosed above and in those applications incorporated hereinby reference as presented above.

In some aspects, the visualization system 108 may be integrated into asurgical system 100 as disclosed above and depicted in FIGS. 1 and 2 .In addition to the visualization system 108, the surgical system 100 mayinclude one or more hand-held intelligent instruments 112, amulti-functional robotic system 110, one or more visualization systems108, and a centralized surgical hub system 106, among other components.The centralized surgical hub system 106 may control several functions adisclosed above and also depicted in FIG. 3 . In one non-limitingexample, such functions may include supplying and controlling power toany number of powered surgical devices. In another non-limiting example,such functions may include controlling fluid supplied to and evacuatedfrom the surgical site. The centralized surgical hub system 106 may alsobe configured to manage and analyze data received from any of thesurgical system components as well as communicate data and otherinformation among and between the components of the surgical system. Thecentralized surgical hub system 106 may also be in data communicationwith a cloud computing system 104 as disclosed above and depicted, forexample, in FIG. 1 .

In some non-limiting examples, imaging data generated by thevisualization system 108 may be analyzed by on-board computationalcomponents of the visualization system 108, and analysis results may becommunicated to the centralized surgical hub 106. In alternativenon-limiting examples, the imaging data generated by the visualizationsystem 108 may be communicated directly to the centralized surgical hub106 where the data may be analyzed by computational components in thehub system 106. The centralized surgical hub 106 may communicate theimage analysis results to any one or more of the other components of thesurgical system. In some other non-limiting examples, the centralizedsurgical hub may communicate the image data and/or the image analysisresults to the cloud computing system 104.

FIGS. 22A-D and FIGS. 23A-F depict various aspects of one example of avisualization system 2108 that may be incorporated into a surgicalsystem. The visualization system 2108 may include an imaging controlunit 2002 and a hand unit 2020. The imaging control unit 2002 mayinclude one or more illumination sources, a power supply for the one ormore illumination sources, one or more types of data communicationinterfaces (including USB, Ethernet, or wireless interfaces 2004), andone or more a video outputs 2006. The imaging control unit 2002 mayfurther include an interface, such as a USB interface 2010, configuredto transmit integrated video and image capture data to a USB enableddevice. The imaging control unit 2002 may also include one or morecomputational components including, without limitation, a processorunit, a transitory memory unit, a non-transitory memory unit, an imageprocessing unit, a bus structure to form data links among thecomputational components, and any interface (e.g. input and/or output)devices necessary to receive information from and transmit informationto components not included in the imaging control unit. Thenon-transitory memory may further contain instructions that whenexecuted by the processor unit, may perform any number of manipulationsof data that may be received from the hand unit 2020 and/orcomputational devices not included in the imaging control unit.

The illumination sources may include a white light source 2012 and oneor more laser light sources. The imaging control unit 2002 may includeone or more optical and/or electrical interfaces for optical and/orelectrical communication with the hand unit 2020. The one or more laserlight sources may include, as non-limiting examples, any one or more ofa red laser light source, a green laser light source, a blue laser lightsource, an infra red laser light source, and an ultraviolet laser lightsource. In some non-limiting examples, the red laser light source maysource illumination having a peak wavelength that may range between 635nm and 660 nm, inclusive. Non-limiting examples of a red laser peakwavelength may include about 635 nm, about 640 nm, about 645 nm, about650 nm, about 655 nm, about 660 nm, or any value or range of valuestherebetween. In some non-limiting examples, the green laser lightsource may source illumination having a peak wavelength that may rangebetween 520 nm and 532 nm, inclusive. Non-limiting examples of a greenlaser peak wavelength may include about 520 nm, about 522 nm, about 524nm, about 526 nm, about 528 nm, about 530 nm, about 532 nm, or any valueor range of values therebetween. In some non-limiting examples, the bluelaser light source may source illumination having a peak wavelength thatmay range between 405 nm and 445 nm, inclusive. Non-limiting examples ofa blue laser peak wavelength may include about 405 nm, about 410 nm,about 415 nm, about 420 nm, about 425 nm, about 430 nm, about 435 nm,about 440 nm, about 445 nm, or any value or range of valuestherebetween. In some non-limiting examples, the infra red laser lightsource may source illumination having a peak wavelength that may rangebetween 750 nm and 3000 nm, inclusive. Non-limiting examples of an infrared laser peak wavelength may include about 750 nm, about 1000 nm, about1250 nm, about 1500 nm, about 1750 nm, about 2000 nm, about 2250 nm,about 2500 nm, about 2750 nm, 3000 nm, or any value or range of valuestherebetween. In some non-limiting examples, the ultraviolet laser lightsource may source illumination having a peak wavelength that may rangebetween 200 nm and 360 nm, inclusive. Non-limiting examples of anultraviolet laser peak wavelength may include about 200 nm, about 220nm, about 240 nm, about 260 nm, about 280 nm, about 300 nm, about 320nm, about 340 nm, about 360 nm, or any value or range of valuestherebetween.

In one non-limiting aspect, the hand unit 2020 may include a body 2021,a camera scope cable 2015 attached to the body 2021, and an elongatedcamera probe 2024. The body 2021 of the hand unit 2020 may include handunit control buttons 2022 or other controls to permit a healthprofessional using the hand unit 2020 to control the operations of thehand unit 2020 or other components of the imaging control unit 2002,including, for example, the light sources. The camera scope cable 2015may include one or more electrical conductors and one or more opticalfibers. The camera scope cable 2015 may terminate with a camera headconnector 2008 at a proximal end in which the camera head connector 2008is configured to mate with the one or more optical and/or electricalinterfaces of the imaging control unit 2002. The electrical conductorsmay supply power to the hand unit 2020, including the body 2021 and theelongated camera probe 2024, and/or to any electrical componentsinternal to the hand unit 2020 including the body 2021 and/or elongatedcamera probe 2024. The electrical conductors may also serve to providebi-directional data communication between any one or more components thehand unit 2020 and the imaging control unit 2002. The one or moreoptical fibers may conduct illumination from the one or moreillumination sources in the imaging control unit 2002 through the handunit body 2021 and to a distal end of the elongated camera probe 2024.In some non-limiting aspects, the one or more optical fibers may alsoconduct light reflected or refracted from the surgical site to one ormore optical sensors disposed in the elongated camera probe 2024, thehand unit body 2021, and/or the imaging control unit 2002.

FIG. 22B (a top plan view) depicts in more detail some aspects of a handunit 2020 of the visualization system 2108. The hand unit body 2021 maybe constructed of a plastic material. The hand unit control buttons 2022or other controls may have a rubber overmolding to protect the controlswhile permitting them to be manipulated by the surgeon. The camera scopecable 2015 may have optical fibers integrated with electricalconductors, and the camera scope cable 2015 may have a protective andflexible overcoating such as PVC. In some non-limiting examples, thecamera scope cable 2015 may be about 10 ft. long to permit ease of useduring a surgical procedure. The length of the camera scope cable 2015may range from about 5 ft. to about 15 ft. Non-limiting examples of alength of the camera scope cable 2015 may be about 5 ft., about 6 ft.,about 7 ft., about 8 ft., about 9 ft., about 10 ft., about 11 ft., about12 ft., about 13 ft., about 14 ft., about 15 ft., or any length or rangeof lengths therebetween. The elongated camera probe 2024 may befabricated from a rigid material such as stainless steel. In someaspects, the elongated camera probe 2024 may be joined with the handunit body 2021 via a rotatable collar 2026. The rotatable collar 2026may permit the elongated camera probe 2024 to be rotated with respect tothe hand unit body 2021. In some aspects, the elongated camera probe2024 may terminate at a distal end with a plastic window 2028 sealedwith epoxy.

The side plan view of the hand unit, depicted in FIG. 22C illustratesthat a light or image sensor 2030 maybe disposed at a distal end 2032 aof the elongated camera probe or within the hand unit body 2032 b. Insome alternative aspects, the light or image sensor 2030 may be disposewith additional optical elements in the imaging control unit 2002. FIG.22C further depicts an example of a light sensor 2030 comprising a CMOSimage sensor 2034 disposed within a mount 2036 having a radius of about4 mm. FIG. 22D illustrates aspects of the CMOS image sensor 2034,depicting the active area 2038 of the image sensor. Although the CMOSimage sensor in FIG. 22C is depicted to be disposed within a mount 2036having a radius of about 4 mm, it may be recognized that such a sensorand mount combination may be of any useful size to be disposed withinthe elongated camera probe 2024, the hand unit body 2021, or in theimage control unit 2002. Some non-limiting examples of such alternativemounts may include a 5.5 mm mount 2136 a, a 4 mm mount 2136 b, a 2.7 mmmount 2136 c, and a 2 mm mount 2136 d. It may be recognized that theimage sensor may also comprise a CCD image sensor. The CMOS or CCDsensor may comprise an array of individual light sensing elements(pixels).

FIGS. 23A-23F depict various aspects of some examples of illuminationsources and their control that may be incorporated into thevisualization system 2108.

FIG. 23A illustrates an aspect of a laser illumination system having aplurality of laser bundles emitting a plurality of wavelengths ofelectromagnetic energy. As can be seen in the figure, the illuminationsystem 2700 may comprise a red laser bundle 2720, a green laser bundle2730, and a blue laser bundle 2740 that are all optically coupledtogether though fiber optics 2755. As can be seen in the figure, each ofthe laser bundles may have a corresponding light sensing element orelectromagnetic sensor 2725, 2735, 2745 respectively, for sensing theoutput of the specific laser bundle or wavelength.

Additional disclosures regarding the laser illumination system depictedin FIG. 23A for use in a surgical visualization system 2108 may be foundin U.S. Patent Application Publication No. 2014/0268860, titledCONTROLLING THE INTEGRAL LIGHT ENERGY OF A LASER PULSE filed on Mar. 15,2014, which issued on Oct. 3, 2017 as U.S. Pat. No. 9,777,913, thecontents thereof being incorporated by reference herein in its entiretyand for all purposes.

FIG. 23B illustrates the operational cycles of a sensor used in rollingreadout mode. It will be appreciated that the x direction corresponds totime and the diagonal lines 2202 indicate the activity of an internalpointer that reads out each frame of data, one line at time. The samepointer is responsible for resetting each row of pixels for the nextexposure period. The net integration time for each row 2219 a-c isequivalent, but they are staggered in time with respect to one anotherdue to the rolling reset and read process. Therefore, for any scenarioin which adjacent frames are required to represent differentconstitutions of light, the only option for having each row beconsistent is to pulse the light between the readout cycles 2230 a-c.More specifically, the maximum available period corresponds to the sumof the blanking time plus any time during which optical black oroptically blind (OB) rows (2218, 2220) are serviced at the start or endof the frame.

FIG. 23B illustrates the operational cycles of a sensor used in rollingreadout mode or during the sensor readout 2200. The frame readout maystart at and may be represented by vertical line 2210. The read outperiod is represented by the diagonal or slanted line 2202. The sensormay be read out on a row by row basis, the top of the downwards slantededge being the sensor top row 2212 and the bottom of the downwardsslanted edge being the sensor bottom row 2214. The time between the lastrow readout and the next readout cycle may be called the blanking time2216 a-d. It may be understood that the blanking time 2216 a-d may bethe same between success readout cycles or it may differ between successreadout cycles. It should be noted that some of the sensor pixel rowsmight be covered with a light shield (e.g., a metal coating or any othersubstantially black layer of another material type). These covered pixelrows may be referred to as optical black rows 2218 and 2220. Opticalblack rows 2218 and 2220 may be used as input for correction algorithms.

As shown in FIG. 23B, these optical black rows 2218 and 2220 may belocated on the top of the pixel array or at the bottom of the pixelarray or at the top and the bottom of the pixel array. In some aspects,it may be desirable to control the amount of electromagnetic radiation,e.g., light, that is exposed to a pixel, thereby integrated oraccumulated by the pixel. It will be appreciated that photons areelementary particles of electromagnetic radiation. Photons areintegrated, absorbed, or accumulated by each pixel and converted into anelectrical charge or current. In some aspects, an electronic shutter orrolling shutter may be used to start the integration time (2219 a-c) byresetting the pixel. The light will then integrate until the nextreadout phase. In some aspects, the position of the electronic shuttercan be moved between two readout cycles 2202 in order to control thepixel saturation for a given amount of light. In some alternativeaspects lacking an electronic shutter, the integration time 2219 a-c ofthe incoming light may start during a first readout cycle 2202 and mayend at the next readout cycle 2202, which also defines the start of thenext integration. In some alternative aspects, the amount of lightaccumulated by each pixel may be controlled by a time during which lightis pulsed 2230 a-d during the blanking times 2216 a-d. This ensures thatall rows see the same light issued from the same light pulse 2230 a-c.In other words, each row will start its integration in a first darkenvironment 2231, which may be at the optical black back row 2220 ofread out frame (m) for a maximum light pulse width, and will thenreceive a light strobe and will end its integration in a second darkenvironment 2232, which may be at the optical black front row 2218 ofthe next succeeding read out frame (m+1) for a maximum light pulsewidth. Thus, the image generated from the light pulse 2230 a-c will besolely available during frame (m+1) readout without any interferencewith frames (m) and (m+2).

It should be noted that the condition to have a light pulse 2230 a-c tobe read out only in one frame and not interfere with neighboring framesis to have the given light pulse 2230 a-c firing during the blankingtime 2216. Because the optical black rows 2218, 2220 are insensitive tolight, the optical black back rows 2220 time of frame (m) and theoptical black front rows 2218 time of frame (m+1) can be added to theblanking time 2216 to determine the maximum range of the firing time ofthe light pulse 2230.

In some aspects, FIG. 23B depicts an example of a timing diagram forsequential frame captures by a conventional CMOS sensor. Such a CMOSsensor may incorporate a Bayer pattern of color filters, as depicted inFIG. 23C. It is recognized that the Bayer pattern provides for greaterluminance detail than chrominance. It may further be recognized that thesensor has a reduced spatial resolution since a total of 4 adjacentpixels are required to produce the color information for the aggregatespatial portion of the image. In an alternative approach, the colorimage may be constructed by rapidly strobing the visualized area at highspeed with a variety of optical sources (either laser or light-emittingdiodes) having different central optical wavelengths.

The optical strobing system may be under the control of the camerasystem, and may include a specially designed CMOS sensor with high speedreadout. The principal benefit is that the sensor can accomplish thesame spatial resolution with significantly fewer pixels compared withconventional Bayer or 3-sensor cameras. Therefore, the physical spaceoccupied by the pixel array may be reduced. The actual pulse periods(2230 a-c) may differ within the repeating pattern, as illustrated inFIG. 23B. This is useful for, e.g., apportioning greater time to thecomponents that require the greater light energy or those having theweaker sources. As long as the average captured frame rate is an integermultiple of the requisite final system frame rate, the data may simplybe buffered in the signal processing chain as appropriate.

The facility to reduce the CMOS sensor chip-area to the extent allowedby combining all of these methods is particularly attractive for smalldiameter (˜3-10 mm) endoscopy. In particular, it allows for endoscopedesigns in which the sensor is located in the space-constrained distalend, thereby greatly reducing the complexity and cost of the opticalsection, while providing high definition video. A consequence of thisapproach is that to reconstruct each final, full color image, requiresthat data be fused from three separate snapshots in time. Any motionwithin the scene, relative to the optical frame of reference of theendoscope, will generally degrade the perceived resolution, since theedges of objects appear at slightly different locations within eachcaptured component. In this disclosure, a means of diminishing thisissue is described which exploits the fact that spatial resolution ismuch more important for luminance information, than for chrominance.

The basis of the approach is that, instead of firing monochromatic lightduring each frame, combinations of the three wavelengths are used toprovide all of the luminance information within a single image. Thechrominance information is derived from separate frames with, e.g., arepeating pattern such as Y-Cb-Y-Cr (FIG. 23D). While it is possible toprovide pure luminance data by a shrewd choice of pulse ratios, the sameis not true of chrominance.

In one aspect, as illustrated in FIG. 23D, an endoscopic system 2300 amay comprise a pixel array 2302 a having uniform pixels and the system2300 a may be operated to receive Y (luminance pulse) 2304 a, Cb(ChromaBlue) 2306 a and Cr (ChromaRed) 2308 a pulses.

To complete a full color image requires that the two components ofchrominance also be provided. However, the same algorithm that wasapplied for luminance cannot be directly applied for chrominance imagessince it is signed, as reflected in the fact that some of the RGBcoefficients are negative. The solution to this is to add a degree ofluminance of sufficient magnitude that all of the final pulse energiesbecome positive. As long as the color fusion process in the ISP is awareof the composition of the chrominance frames, they can be decoded bysubtracting the appropriate amount of luminance from a neighboringframe. The pulse energy proportions are given by:Y=0.183·R+0.614·G+0.062·BCb=λ·Y−0.101·R−0.339·G+0.439·BCr=δ·Y+0.439·R−0.399·G−0.040·Bwhereλ≥0.399/0.614=0.552δ≥0.399/0.614=0.650

It turns out that if the A factor is equal to 0.552; both the red andthe green components are exactly cancelled, in which case the Cbinformation can be provided with pure blue light. Similarly, settingδ=0.650 cancels out the blue and green components for Cr which becomespure red. This particular example is illustrated in FIG. 23E, which alsodepicts λ and δ as integer multiples of ½⁸. This is a convenientapproximation for the digital frame reconstruction.

In the case of the Y-Cb-Y-Cr pulsing scheme, the image data is alreadyin the YCbCr space following the color fusion. Therefore, in this caseit makes sense to perform luminance and chrominance based operations upfront, before converting back to linear RGB to perform the colorcorrection etc.

The color fusion process is more straightforward than de-mosaic, whichis necessitated by the Bayer pattern (see FIG. 23C), since there is nospatial interpolation. It does require buffering of frames though inorder to have all of the necessary information available for each pixel.In one general aspect, data for the Y-Cb-Y-Cr pattern may be pipelinedto yield one full color image per two raw captured images. This isaccomplished by using each chrominance sample twice. In FIG. 23F thespecific example of a 120 Hz frame capture rate providing 60 Hz finalvideo is depicted.

Additional disclosures regarding the control of the laser components ofan illumination system as depicted in FIGS. 23B-23F for use in asurgical visualization system 108 may be found in U.S. PatentApplication Publication No. 2014/0160318, titled YCBCR PULSEDILLUMINATION SCHEME IN A LIGHT DEFICIENT ENVIRONMENT, filed on Jul. 26,2013, which issued on Dec. 6, 2016 as U.S. Pat. No. 9,516,239, and U.S.Patent Application Publication No. 2014/0160319, titled CONTINUOUS VIDEOIN A LIGHT DEFICIENT ENVIRONMENT, filed on Jul. 26, 2013, which issuedon Aug. 22, 2017 as U.S. Pat. No. 9,743,016, the contents thereof beingincorporated by reference herein in their entirety and for all purposes.

Subsurface Vascular Imaging

During a surgical procedure, a surgeon may be required to manipulatetissues to effect a desired medical outcome. The actions of the surgeonare limited by what is visually observable in the surgical site. Thus,the surgeon may not be aware, for example, of the disposition ofvascular structures that underlie the tissues being manipulated duringthe procedure.

Since the surgeon is unable to visualize the vasculature beneath asurgical site, the surgeon may accidentally sever one or more criticalblood vessels during the procedure.

Therefore, it is desirable to have a surgical visualization system thatcan acquire imaging data of the surgical site for presentation to asurgeon in which the presentation can include information related to thepresence of vascular structures located beneath the surface of asurgical site.

Some aspects of the present disclosure further provide for a controlcircuit configured to control the illumination of a surgical site usingone or more illumination sources such as laser light sources and toreceive imaging data from one or more image sensors. In some aspects,the present disclosure provides for a non-transitory computer readablemedium storing computer readable instructions that, when executed, causea device to detect a blood vessel in a tissue and determine its depthbelow the surface of the tissue.

In some aspects, a surgical image acquisition system may include aplurality of illumination sources wherein each illumination source isconfigured to emit light having a specified central wavelength, a lightsensor configured to receive a portion of the light reflected from atissue sample when illuminated by the one or more of the plurality ofillumination sources, and a computing system. The computing system maybe configured to: receive data from the light sensor when the tissuesample is illuminated by each of the plurality of illumination sources;determine a depth location of a structure within the tissue sample basedon the data received by the light sensor when the tissue sample isilluminated by each of the plurality of illumination sources, andcalculate visualization data regarding the structure and the depthlocation of the structure. In some aspects, the visualization data mayhave a data format that may be used by a display system, and thestructure may comprise one or more vascular tissues.

Vascular Imaging Using NIR Spectroscopy

In one aspect, a surgical image acquisition system may include anindependent color cascade of illumination sources comprising visiblelight and light outside of the visible range to image one or moretissues within a surgical site at different times and at differentdepths. The surgical image acquisition system may further detect orcalculate characteristics of the light reflected and/or refracted fromthe surgical site. The characteristics of the light may be used toprovide a composite image of the tissue within the surgical site as wellas provide an analysis of underlying tissue not directly visible at thesurface of the surgical site. The surgical image acquisition system maydetermine tissue depth location without the need for separatemeasurement devices.

In one aspect, the characteristic of the light reflected and/orrefracted from the surgical site may be an amount of absorbance of lightat one or more wavelengths. Various chemical components of individualtissues may result in specific patterns of light absorption that arewavelength dependent.

In one aspect, the illumination sources may comprise a red laser sourceand a near infrared laser source, wherein the one or more tissues to beimaged may include vascular tissue such as veins or arteries. In someaspects, red laser sources (in the visible range) may be used to imagesome aspects of underlying vascular tissue based on spectroscopy in thevisible red range. In some non-limiting examples, a red laser lightsource may source illumination having a peak wavelength that may rangebetween 635 nm and 660 nm, inclusive. Non-limiting examples of a redlaser peak wavelength may include about 635 nm, about 640 nm, about 645nm, about 650 nm, about 655 nm, about 660 nm, or any value or range ofvalues therebetween. In some other aspects, near infrared laser sourcesmay be used to image underlying vascular tissue based on near infraredspectroscopy. In some non-limiting examples, a near infrared lasersource may emit illumination have a wavelength that may range between750-3000 nm, inclusive. Non-limiting examples of an infra red laser peakwavelength may include about 750 nm, about 1000 nm, about 1250 nm, about1500 nm, about 1750 nm, about 2000 nm, about 2250 nm, about 2500 nm,about 2750 nm, 3000 nm, or any value or range of values therebetween. Itmay be recognized that underlying vascular tissue may be probed using acombination of red and infrared spectroscopy. In some examples, vasculartissue may be probed using a red laser source having a peak wavelengthat about 660 nm and a near IR laser source having a peak wavelength atabout 750 nm or at about 850 nm.

Near infrared spectroscopy (NIRS) is a non-invasive technique thatallows determination of tissue oxygenation based on spectro-photometricquantitation of oxy- and deoxyhemoglobin within a tissue. In someaspects, NIRS can be used to image vascular tissue directly based on thedifference in illumination absorbance between the vascular tissue andnon-vascular tissue. Alternatively, vascular tissue can be indirectlyvisualized based on a difference of illumination absorbance of bloodflow in the tissue before and after the application of physiologicalinterventions, such as arterial and venous occlusions methods.

Instrumentation for near-IR (NIR) spectroscopy may be similar toinstruments for the UV-visible and mid-IR ranges. Such spectroscopicinstruments may include an illumination source, a detector, and adispersive element to select a specific near-IR wavelength forilluminating the tissue sample. In some aspects, the source may comprisean incandescent light source or a quartz halogen light source. In someaspects, the detector may comprise semiconductor (for example, anInGaAs) photodiode or photo array. In some aspects, the dispersiveelement may comprise a prism or, more commonly, a diffraction grating.Fourier transform NIR instruments using an interferometer are alsocommon, especially for wavelengths greater than about 1000 nm. Dependingon the sample, the spectrum can be measured in either reflection ortransmission mode.

FIG. 24 depicts schematically one example of instrumentation 2400similar to instruments for the UV-visible and mid-IR ranges for NIRspectroscopy. A light source 2402 may emit a broad spectral range ofillumination 2404 that may impinge upon a dispersive element 2406 (suchas a prism or a diffraction grating). The dispersive element 2406 mayoperate to select a narrow wavelength portion 2408 of the light emittedby the broad spectrum light source 2402, and the selected portion 2408of the light may illuminate the tissue 2410. The light reflected fromthe tissue 2412 may be directed to a detector 2416 (for example, bymeans of a dichroic mirror 2414) and the intensity of the reflectedlight 2412 may be recorded. The wavelength of the light illuminating thetissue 2410 may be selected by the dispersive element 2406. In someaspects, the tissue 2410 may be illuminated only by a single narrowwavelength portion 2408 selected by the dispersive element 2406 form thelight source 2402. In other aspects, the tissue 2410 may be scanned witha variety of narrow wavelength portions 2408 selected by the dispersiveelement 2406. In this manner, a spectroscopic analysis of the tissue2410 may be obtained over a range of NIR wavelengths.

FIG. 25 depicts schematically one example of instrumentation 2430 fordetermining NIRS based on Fourier transform infrared imaging. In FIG. 25, a laser source emitting 2432 light in the near IR range 2434illuminates a tissue sample 2440. The light reflected 2436 by the tissue2440 is reflected 2442 by a mirror, such as a dichroic mirror 2444, to abeam splitter 2446. The beam splitter 2446 directs one portion of thelight 2448 reflected 2436 by the tissue 2440 to a stationary mirror 2450and one portion of the light 2452 reflected 2436 by the tissue 2440 amoving mirror 2454. The moving mirror 2454 may oscillate in positionbased on an affixed piezoelectric transducer activated by a sinusoidalvoltage having a voltage frequency. The position of the moving mirror2454 in space corresponds to the frequency of the sinusoidal activationvoltage of the piezoelectric transducer. The light reflected from themoving mirror and the stationary mirror may be recombined 2458 at thebeam splitter 2446 and directed to a detector 2456. Computationalcomponents may receive the signal output of the detector 2456 andperform a Fourier transform (in time) of the received signal. Becausethe wavelength of the light received from the moving mirror 2454 variesin time with respect to the wavelength of the light received from thestationary mirror 2450, the time-based Fourier transform of therecombined light corresponds to a wavelength-based Fourier transform ofthe recombined light 2458. In this manner, a wavelength-based spectrumof the light reflected from the tissue 2440 may be determined andspectral characteristics of the light reflected 2436 from the tissue2440 may be obtained. Changes in the absorbance of the illumination inspectral components from the light reflected from the tissue 2440 maythus indicate the presence or absence of tissue having specific lightabsorbing properties (such as hemoglobin).

An alternative to near infrared light to determine hemoglobinoxygenation would be the use of monochromatic red light to determine thered light absorbance characteristics of hemoglobin. The absorbancecharacteristics of red light having a central wavelength of about 660 nmby the hemoglobin may indicate if the hemoglobin is oxygenated (arterialblood) or deoxygenated (venous blood).

In some alternative surgical procedures, contrasting agents can be usedto improve the data that is collected on oxygenation and tissue oxygenconsumption. In one non-limiting example, NIRS techniques may be used inconjunction with a bolus injection of a near-IR contrast agent such asindocyanine green (ICG) which has a peak absorbance at about 800 nm. ICGhas been used in some medical procedures to measure cerebral blood flow.

Vascular Imaging Using Laser Doppler Flowmetry

In one aspect, the characteristic of the light reflected and/orrefracted from the surgical site may be a Doppler shift of the lightwavelength from its illumination source.

Laser Doppler flowmetry may be used to visualize and characterized aflow of particles moving relative to an effectively stationarybackground. Thus, laser light scattered by moving particles, such asblood cells, may have a different wavelength than that of the originalilluminating laser source. In contrast, laser light scattered by theeffectively stationary background (for example, the vascular tissue) mayhave the same wavelength of that of the original illuminating lasersource. The change in wavelength of the scattered light from the bloodcells may reflect both the direction of the flow of the blood cellsrelative to the laser source as well as the blood cell velocity. FIGS.26A-C illustrate the change in wavelength of light scattered from bloodcells that may be moving away from (FIG. 26A) or towards (FIG. 26C) thelaser light source.

In each of FIGS. 26A-C, the original illuminating light 2502 is depictedhaving a relative central wavelength of 0. It may be observed from FIG.26A that light scattered from blood cells moving away from the lasersource 2504 has a wavelength shifted by some amount 2506 to a greaterwavelength relative to that of the laser source (and is thus redshifted). It may also be observed from FIG. 26C that light scatteredfrom blood cells moving towards from the laser source 2508 has awavelength shifted by some amount 2510 to a shorter wavelength relativeto that of the laser source (and is thus blue shifted). The amount ofwavelength shift (for example 2506 or 2510) may be dependent on thevelocity of the motion of the blood cells. In some aspects, an amount ofa red shift (2506) of some blood cells may be about the same as theamount of blue shift (2510) of some other blood cells. Alternatively, anamount of a red shift (2506) of some blood cells may differ from theamount of blue shift (2510) of some other blood cells Thus, the velocityof the blood cells flowing away from the laser source as depicted inFIG. 26A may be less than the velocity of the blood cells flowingtowards the laser source as depicted in FIG. 26C based on the relativemagnitude of the wavelength shifts (2506 and 2510). In contrast, and asdepicted in FIG. 26B, light scattered from tissue not moving relative tothe laser light source (for example blood vessels 2512 or non-vasculartissue 2514) may not demonstrate any change in wavelength.

FIG. 27 depicts an aspect of instrumentation 2530 that may be used todetect a Doppler shift in laser light scattered from portions of atissue 2540. Light 2534 originating from a laser 2532 may pass through abeam splitter 2544. Some portion of the laser light 2536 may betransmitted by the beam splitter 2544 and may illuminate tissue 2540.Another portion of the laser light may be reflected 2546 by the beamsplitter 2544 to impinge on a detector 2550. The light back-scattered2542 by the tissue 2540 may be directed by the beam splitter 2544 andalso impinge on the detector 2550. The combination of the light 2534originating from the laser 2532 with the light back-scattered 2542 bythe tissue 2540 may result in an interference pattern detected by thedetector 2550. The interference pattern received by the detector 2550may include interference fringes resulting from the combination of thelight 2534 originating from the laser 2532 and the Doppler shifted (andthus wavelength shifted) light back-scattered 2452 from the tissue 2540.

It may be recognized that back-scattered light 2542 from the tissue 2540may also include back scattered light from boundary layers within thetissue 2540 and/or wavelength-specific light absorption by materialwithin the tissue 2540. As a result, the interference pattern observedat the detector 2550 may incorporate interference fringe features fromthese additional optical effects and may therefore confound thecalculation of the Doppler shift unless properly analyzed.

FIG. 28 depicts some of these additional optical effects. It is wellknown that light traveling through a first optical medium having a firstrefractive index, n1, may be reflected at an interface with a secondoptical medium having a second refractive index, n2. The lighttransmitted through the second optical medium will have a transmissionangle relative to the interface that differs from the angle of theincident light based on a difference between the refractive indices n1and n2 (Snell's Law). FIG. 28 illustrates the effect of Snell's Law onlight impinging on the surface of a multi-component tissue 2150, as maybe presented in a surgical field. The multi-component tissue 2150 may becomposed of an outer tissue layer 2152 having a refractive index n1 anda buried tissue, such as a blood vessel having a vessel wall 2156. Theblood vessel wall 2156 may be characterized by a refractive index n2.Blood may flow within the lumen of the blood vessel 2160. In someaspects, it may be important during a surgical procedure to determinethe position of the blood vessel 2160 below the surface 2154 of theouter tissue layer 2152 and to characterize the blood flow using Dopplershift techniques.

An incident laser light 2170 a may be used to probe for the blood vessel2160 and may be directed on the top surface 2154 of the outer tissuelayer 2152. A portion 2172 of the incident laser light 2170 a may bereflected at the top surface 2154. Another portion 2170 b of theincident laser light 2170 a may penetrate the outer tissue layer 2152.The reflected portion 2172 at the top surface 2154 of the outer tissuelayer 2152 has the same path length of the incident light 2170 a, andtherefore has the same wavelength and phase of the incident light 2170a. However, the portion 2170 b of light transmitted into the outertissue layer 2152 will have a transmission angle that differs from theincidence angle of the light impinging on the tissue surface because theouter tissue layer 2152 has an index of refraction n1 that differs fromthe index of refraction of air.

If the portion of light transmitted through the outer tissue layer 2152impinges on a second tissue surface 2158, for example of the bloodvessel wall 2156, some portion 2174 a,b of light will be reflected backtowards the source of the incident light 2170 a. The light thusreflected 2174 a at the interface between the outer tissue layer 2152and the blood vessel wall 2156 will have the same wavelength as theincident light 2170 a, but will be phase shifted due to the change inthe light path length. Projecting the light reflected 2174 a,b from theinterface between the outer tissue layer 2152 and the blood vessel wall2156 along with the incident light on the sensor, will produce aninterference pattern based on the phase difference between the two lightsources.

Further, a portion of the incident light 2170 c may be transmittedthrough the blood vessel wall 2156 and penetrate into the blood vessellumen 2160. This portion of the incident light 2170 c may interact withthe moving blood cells in the blood vessel lumen 2160 and may bereflected back 2176 a-c towards the source of the impinging light havinga wavelength Doppler shifted according to the velocity of the bloodcells, as disclosed above. The Doppler shifted light reflected 2176 a-cfrom the moving blood cells may be projected along with the incidentlight on the sensor, resulting in an interference pattern having afringe pattern based on the wavelength difference between the two lightsources.

In FIG. 28 , a light path 2178 is presented of light impinging on thered blood cells in the blood vessel lumen 2160 if there are no changesin refractive index between the emitted light and the light reflected bythe moving blood cells. In this example, only a Doppler shift in thereflected light wavelength can be detected. However, the light reflectedby the blood cells (2176 a-c) may incorporate phase changes due to thevariation in the tissue refractive indices in addition to the wavelengthchanges due to the Doppler Effect.

Thus, it may be understood that if the light sensor receives theincident light, the light reflected from one or more tissue interfaces(2172, and 2174 a,b) and the Doppler shifted light from the blood cells(2176 a-c), the interference pattern thus produced on the light sensormay include the effects due to the Doppler shift (change in wavelength)as well as the effects due to the change in refractive index within thetissue (change in phase). As a result, a Doppler analysis of the lightreflected by the tissue sample may produce erroneous results if theeffects due to changes in the refractive index within the sample are notcompensated for.

FIG. 29 illustrates an example of the effects on a Doppler analysis oflight that impinge 2250 on a tissue sample to determine the depth andlocation of an underlying blood vessel. If there is no interveningtissue between the blood vessel and the tissue surface, the interferencepattern detected at the sensor may be due primarily to the change inwavelength reflected from the moving blood cells. As a result, aspectrum 2252 derived from the interference pattern may generallyreflect only the Doppler shift of the blood cells. However, if there isintervening tissue between the blood vessel and the tissue surface, theinterference pattern detected at the sensor may be due to a combinationof the change in wavelength reflected from the moving blood cells andthe phase shift due to the refractive index of the intervening tissue. Aspectrum 2254 derived from such an interference pattern, may result inthe calculation of the Doppler shift that is confounded due to theadditional phase change in the reflected light. In some aspects, ifinformation regarding the characteristics (thickness and refractiveindex) of the intervening tissue is known, the resulting spectrum 2256may be corrected to provide a more accurate calculation of the change inwavelength.

It is recognized that the tissue penetration depth of light is dependenton the wavelength of the light used. Thus, the wavelength of the lasersource light may be chosen to detect particle motion (such a bloodcells) at a specific range of tissue depth. FIGS. 30A-C depictschematically a means for detect moving particles such as blood cells ata variety of tissue depths based on the laser light wavelength. Asillustrated in FIG. 30A, a laser source 2340 may direct an incident beamof laser light 2342 onto a surface 2344 of a surgical site. A bloodvessel 2346 (such as a vein or artery) may be disposed within the tissue2348 at some depth δ from the tissue surface. The penetration depth 2350of a laser into a tissue 2348 may be dependent at least in part on thelaser wavelength. Thus, laser light having a wavelength in the red rangeof about 635 nm to about 660 nm, may penetrate the tissue 2351 a to adepth of about 1 mm. Laser light having a wavelength in the green rangeof about 520 nm to about 532 nm may penetrate the tissue 2351 b to adepth of about 2-3 mm. Laser light having a wavelength in the blue rangeof about 405 nm to about 445 nm may penetrate the tissue 2351 c to adepth of about 4 mm or greater. In the example depicted in FIGS. 30A-C,a blood vessel 2346 may be located at a depth δ of about 2-3 mm belowthe tissue surface. Red laser light will not penetrate to this depth andthus will not detect blood cells flowing within this vessel. However,both green and blue laser light can penetrate this depth. Therefore,scattered green and blue laser light from the blood cells within theblood vessel 2346 may demonstrate a Doppler shift in wavelength.

FIG. 30B illustrates how a Doppler shift 2355 in the wavelength ofreflected laser light may appear. The emitted light (or laser sourcelight 2342) impinging on a tissue surface 2344 may have a centralwavelength 2352. For example, light from a green laser may have acentral wavelength 2352 within a range of about 520 nm to about 532 nm.The reflected green light may have a central wavelength 2354 shifted toa longer wavelength (red shifted) if the light was reflected from aparticle such as a red blood cell that is moving away from the detector.The difference between the central wavelength 2352 of the emitted laserlight and the central wavelength 2354 of the emitted laser lightcomprises the Doppler shift 2355.

As disclosed above with respect to FIGS. 28 and 29 , laser lightreflected from structures within a tissue 2348 may also show a phaseshift in the reflected light due to changes in the index of refractionarising from changes in tissue structure or composition. The emittedlight (or laser source light 2342) impinging on a tissue surface 2344may have a first phase characteristic 2356. The reflected laser lightmay have a second phase characteristic 2358. It may be recognized thatblue laser light that can penetrate tissue to a depth of about 4 mm orgreater 2351 c may encounter a greater variety of tissue structures thanred laser light (about 1 mm 2351 a) or green laser light (about 2-3 mm2351 b). Consequently, as illustrated in FIG. 30C, the phase shift 2358of reflected blue laser light may be significant at least due to thedepth of penetration.

FIG. 30D illustrates aspects of illuminating tissue by red 2360 a, green2360 b and blue 2360 c laser light in a sequential manner. In someaspects, a tissue may be probed by red 2360 a, green 2360 b and blue2360 c laser illumination in a sequential manner. In some alternativeexamples, one or more combinations of red 2360 a, green 2360 b, and blue2360 c laser light, as depicted in FIGS. 23D-23F and disclosed above,may be used to illuminate the tissue according to a defined illuminationsequence. 30D illustrates the effect of such illumination on a CMOSimaging sensor 2362 a-d over time. Thus, at a first time t₁, the CMOSsensor 2362 a may be illuminated by the red 2360 a laser. At a secondtime t₂ the CMOS sensor 2362 b may be illuminated by the green 2360 blaser. At a third time t₃, the CMOS sensor 2362 c may be illuminated bythe blue 2360 c laser. The illumination cycle may then be repeatedstarting at a fourth time t₄ in which the CMOS sensor 2362 d may beilluminated by the red 2360 a laser again. It may be recognized thatsequential illumination of the tissue by laser illumination at differingwavelengths may permit a Doppler analysis at varying tissue depths overtime. Although red 2360 a, green 2360 b and blue 2360 c laser sourcesmay be used to illuminate the surgical site, it may be recognized thatother wavelengths outside of visible light (such as in the infra red orultraviolet regions) may be used to illuminate the surgical site forDoppler analysis.

FIG. 31 illustrates an example of a use of Doppler imaging to detect thepresent of blood vessels not otherwise viewable at a surgical site 2600.In FIG. 31 , a surgeon may wish to excise a tumor 2602 found in theright superior posterior lobe 2604 of a lung. Because the lungs arehighly vascular, care must be taken to identify only those blood vesselsassociate with the tumor and to seal only those vessels withoutcompromising the blood flow to the non-affected portions of the lung. InFIG. 31 , the surgeon has identified the margin 2606 of the tumor 2604.The surgeon may then cut an initial dissected area 2608 in the marginregion 2606, and exposed blood vessels 2610 may be observed for cuttingand sealing. The Doppler imaging detector 2620 may be used to locate andidentify blood vessels not observable 2612 in the dissected area. Animaging system may receive data from the Doppler imaging detector 2620for analysis and display of the data obtained from the surgical site2600. In some aspects, the imaging system may include a display toillustrate the surgical site 2600 including a visible image of thesurgical site 2600 along with an image overlay of the hidden bloodvessels 2612 on the image of the surgical site 2600.

In the scenario disclosed above regarding FIG. 31 , a surgeon wishes tosever blood vessels that supply oxygen and nutrients to a tumor whilesparing blood vessels associated with non-cancerous tissue.Additionally, the blood vessels may be disposed at different depths inor around the surgical site 2600. The surgeon must therefore identifythe position (depth) of the blood vessels as well as determine if theyare appropriate for resection. FIG. 32 illustrates one method foridentifying deep blood vessels based on a Doppler shift of light fromblood cells flowing therethrough. As disclosed above, red laser lighthas a penetration depth of about 1 mm and green laser light has apenetration depth of about 2-3 mm. However, a blood vessel having abelow-surface depth of 4 mm or more will be outside the penetrationdepths at these wavelengths. Blue laser light, however, can detect suchblood vessels based on their blood flow.

FIG. 32 depicts the Doppler shift of laser light reflected from a bloodvessel at a specific depth below a surgical site. The site may beilluminated by red laser light, green laser light, and blue laser light.The central wavelength 2630 of the illuminating light may be normalizedto a relative central 3631. If the blood vessel lies at a depth of 4 ormore mm below the surface of the surgical site, neither the red laserlight nor the green laser light will be reflected by the blood vessel.Consequently, the central wavelength 2632 of the reflected red light andthe central wavelength 2634 of the reflected green light will not differmuch from the central wavelength 2630 of the illuminating red light orgreen light, respectively. However, if the site is illuminated by bluelaser light, the central wavelength 2638 of the reflected blue light2636 will differ from the central wavelength 2630 of the illuminatingblue light. In some instances, the amplitude of the reflected blue light2636 may also be significantly reduced from the amplitude of theilluminating blue light. A surgeon may thus determine the presence of adeep lying blood vessel along with its approximate depth, and therebyavoiding the deep blood vessel during surface tissue dissection.

FIGS. 33 and 34 illustrates schematically the use of laser sourceshaving differing central wavelengths (colors) for determining theapproximate depth of a blood vessel beneath the surface of a surgicalsite. FIG. 33 depicts a first surgical site 2650 having a surface 2654and a blood vessel 2656 disposed below the surface 2654. In one method,the blood vessel 2656 may be identified based on a Doppler shift oflight impinging on the flow 2658 of blood cells within the blood vessel2656. The surgical site 2650 may be illuminated by light from a numberof lasers 2670, 2676, 2682, each laser being characterized by emittinglight at one of several different central wavelengths. As noted above,illumination by a red laser 2670 can only penetrate tissue by about 1mm. Thus, if the blood vessel 2656 was located at a depth of less than 1mm 2672 below the surface 2654, the red laser illumination would bereflected 2674 and a Doppler shift of the reflected red illumination2674 may be determined. Further, as noted above, illumination by a greenlaser 2676 can only penetrate tissue by about 2-3 mm. If the bloodvessel 2656 was located at a depth of about 2-3 mm 2678 below thesurface 2654, the green laser illumination would be reflected 2680 whilethe red laser illumination 2670 would not, and a Doppler shift of thereflected green illumination 2680 may be determined. However, asdepicted in FIG. 33 , the blood vessel 2656 is located at a depth ofabout 4 mm 2684 below the surface 2654. Therefore, neither the red laserillumination 2670 nor the green laser illumination 2676 would bereflected. Instead, only the blue laser illumination would be reflected2686 and a Doppler shift of the reflected blue illumination 2686 may bedetermined.

In contrast to the blood vessel 2656 depicted in FIG. 33 , the bloodvessel 2656′ depicted in FIG. 34 is located closer to the surface of thetissue at the surgical site. Blood vessel 2656′ may also bedistinguished from blood vessel 2656 in that blood vessel 2656′ isillustrated to have a much thicker wall 2657. Thus, blood vessel 2656′may be an example of an artery while blood vessel 2656 may be an exampleof a vein because arterial walls are known to be thicker than venouswalls. In some examples, arterial walls may have a thickness of about1.3 mm. As disclosed above, red laser illumination 2670′ can penetratetissue to a depth of about 1 mm 2672′. Thus, even if a blood vessel2656′ is exposed at a surgical site (see 2610 at FIG. 31 ), red laserlight that is reflected 2674′ from the surface of the blood vessel2656′, may not be able to visualize blood flow 2658′ within the bloodvessel 2656′ under a Doppler analysis due to the thickness of the bloodvessel wall 2657. However, as disclosed above, green laser lightimpinging 2676′ on the surface of a tissue may penetrate to a depth ofabout 2-3 mm 2678′. Further, blue laser light impinging 2682′ on thesurface of a tissue may penetrate to a depth of about 4 mm 2684′.Consequently, green laser light may be reflected 2680′ from the bloodcells flowing 2658′ within the blood vessel 2656′ and blue laser lightmay be reflected 2686′ from the blood cells flowing 2658′ within theblood vessel 2656′. As a result, a Doppler analysis of the reflectedgreen light 2680′ and reflected blue light 2686′ may provide informationregarding blood flow in near-surface blood vessel, especially theapproximate depth of the blood vessel.

As disclosed above, the depth of blood vessels below the surgical sitemay be probed based on wavelength-dependent Doppler imaging. The amountof blood flow through such a blood vessel may also be determined byspeckle contrast (interference) analysis. Doppler shift may indicate amoving particle with respect to a stationary light source. As disclosedabove, the Doppler wavelength shift may be an indication of the velocityof the particle motion. Individual particles such as blood cells may notbe separately observable. However, the velocity of each blood cell willproduce a proportional Doppler shift. An interference pattern may begenerated by the combination of the light back-scattered from multipleblood cells due to the differences in the Doppler shift of theback-scattered light from each of the blood cells. The interferencepattern may be an indication of the number density of blood cells withina visualization frame. The interference pattern may be termed specklecontrast. Speckle contrast analysis may be calculated using a full frame300×300 CMOS imaging array, and the speckle contrast may be directlyrelated to the amount of moving particles (for example blood cells)interacting with the laser light over a given exposure period.

A CMOS image sensor may be coupled to a digital signal processor (DSP).Each pixel of the sensor may be multiplexed and digitized. The Dopplershift in the light may be analyzed by looking at the source laser lightin comparison to the Doppler shifted light. A greater Doppler shift andspeckle may be related to a greater number of blood cells and theirvelocity in the blood vessel.

FIG. 35 depicts an aspect of a composite visual display 2800 that may bepresented a surgeon during a surgical procedure. The composite visualdisplay 2800 may be constructed by overlaying a white light image 2830of the surgical site with a Doppler analysis image 2850.

In some aspects, the white light image 2830 may portray the surgicalsite 2832, one or more surgical incisions 2834, and the tissue 2836readily visible within the surgical incision 2834. The white light image2830 may be generated by illuminating 2840 the surgical site 2832 with awhite light source 2838 and receiving the reflected white light 2842 byan optical detector. Although a white light source 2838 may be used toilluminate the surface of the surgical site, in one aspect, the surfaceof the surgical site may be visualized using appropriate combinations ofred 2854, green 2856, and blue 2858 laser light as disclosed above withrespect to FIGS. 23C-23F.

In some aspects, the Doppler analysis image 2850 may include bloodvessel depth information along with blood flow information 2852 (fromspeckle analysis). As disclosed above, blood vessel depth and blood flowvelocity may be obtained by illuminating the surgical site with laserlight of multiple wavelengths, and determining the blood vessel depthand blood flow based on the known penetration depth of the light of aparticular wavelength. In general, the surgical site 2832 may beilluminated by light emitted by one or more lasers such as a red laser2854, a green laser 2856, and a blue laser 2858. A CMOS detector 2872may receive the light reflected back (2862, 2866, 2870) from thesurgical site 2832 and its surrounding tissue. The Doppler analysisimage 2850 may be constructed 2874 based on an analysis of the multiplepixel data from the CMOS detector 2872.

In one aspect, a red laser 2854 may emit red laser illumination 2860 onthe surgical site 2832 and the reflected light 2862 may reveal surfaceor minimally subsurface structures. In one aspect, a green laser 2856may emit green laser illumination 2864 on the surgical site 2832 and thereflected light 2866 may reveal deeper subsurface characteristics. Inanother aspect, a blue laser 2858 may emit blue laser illumination 2868on the surgical site 2832 and the reflected light 2870 may reveal, forexample, blood flow within deeper vascular structures. In addition, thespeckle contrast analysis my present the surgeon with informationregarding the amount and velocity of blood flow through the deepervascular structures.

Although not depicted in FIG. 35 , it may be understood that the imagingsystem may also illuminate the surgical site with light outside of thevisible range. Such light may include infra red light and ultravioletlight. In some aspects, sources of the infra red light or ultravioletlight may include broad-band wavelength sources (such as a tungstensource, a tungsten-halogen source, or a deuterium source). In some otheraspects, the sources of the infra red or ultraviolet light may includenarrow-band wavelength sources (IR diode lasers, UV gas lasers or dyelasers).

FIG. 36 is a flow chart 2900 of a method for determining a depth of asurface feature in a piece of tissue. An image acquisition system mayilluminate 2910 a tissue with a first light beam having a first centralfrequency and receive 2912 a first reflected light from the tissueilluminated by the first light beam. The image acquisition system maythen calculate 2914 a first Doppler shift based on the first light beamand the first reflected light. The image acquisition system may thenilluminate 2916 the tissue with a second light beam having a secondcentral frequency and receive 2918 a second reflected light from thetissue illuminated by the second light beam. The image acquisitionsystem may then calculate 2920 a second Doppler shift based on thesecond light beam and the second reflected light. The image acquisitionsystem may then calculate 2922 a depth of a tissue feature based atleast in part on the first central wavelength, the first Doppler shift,the second central wavelength, and the second Doppler shift. In someaspects, the tissue features may include the presence of movingparticles, such as blood cells moving within a blood vessel, and adirection and velocity of flow of the moving particles. It may beunderstood that the method may be extended to include illumination ofthe tissue by any one or more additional light beams. Further, thesystem may calculate an image comprising a combination of an image ofthe tissue surface and an image of the structure disposed within thetissue.

In some aspects, multiple visual displays may be used. For example, a 3Ddisplay may provide a composite image displaying the combined whitelight (or an appropriate combination of red, green, and blue laserlight) and laser Doppler image. Additional displays may provide only thewhite light display or a displaying showing a composite white lightdisplay and an NIRS display to visualize only the blood oxygenationresponse of the tissue. However, the NIRS display may not be requiredevery cycle allowing for response of tissue.

Subsurface Tissue Characterization Using Multispectral OCT

During a surgical procedure, the surgeon may employ “smart” surgicaldevices for the manipulation of tissue. Such devices may be considered“smart” in that they include automated features to direct, control,and/or vary the actions of the devices based parameters relevant totheir uses. The parameters may include the type and/or composition ofthe tissue being manipulated. If the type and/or composition of thetissue being manipulated is unknown, the actions of the smart devicesmay be inappropriate for the tissue being manipulated. As a result,tissues may be damaged or the manipulation of the tissue may beineffective due to inappropriate settings of the smart device.

The surgeon may manually attempt to vary the parameters of the smartdevice in a trial-and-error manner, resulting in an inefficient andlengthy surgical procedure.

Therefore, it is desirable to have a surgical visualization system thatcan probe tissue structures underlying a surgical site to determinetheir structural and compositional characteristics, and to provide suchdata to smart surgical instruments being used in a surgical procedure.

Some aspects of the present disclosure further provide for a controlcircuit configured to control the illumination of a surgical site usingone or more illumination sources such as laser light sources and toreceive imaging data from one or more image sensors. In some aspects,the present disclosure provides for a non-transitory computer readablemedium storing computer readable instructions that, when executed, causea device to characterize structures below the surface at a surgical siteand determine the depth of the structures below the surface of thetissue.

In some aspects, a surgical image acquisition system may comprise aplurality of illumination sources wherein each illumination source isconfigured to emit light having a specified central wavelength, a lightsensor configured to receive a portion of the light reflected from atissue sample when illuminated by the one or more of the plurality ofillumination sources, and a computing system. The computing system maybe configured to receive data from the light sensor when the tissuesample is illuminated by each of the plurality of illumination sources,calculate structural data related to a characteristic of a structurewithin the tissue sample based on the data received by the light sensorwhen the tissue sample is illuminated by each of the illuminationsources, and transmit the structural data related to the characteristicof the structure to be received by a smart surgical device. In someaspects, the characteristic of the structure is a surface characteristicor a structure composition.

In one aspect, a surgical system may include multiple laser lightsources and may receive laser light reflected from a tissue. The lightreflected from the tissue may be used by the system to calculate surfacecharacteristics of components disposed within the tissue. Thecharacteristics of the components disposed within the tissue may includea composition of the components and/or a metric related to surfaceirregularities of the components.

In one aspect, the surgical system may transmit data related to thecomposition of the components and/or metrics related to surfaceirregularities of the components to a second instrument to be used onthe tissue to modify the control parameters of the second instrument.

In some aspects, the second device may be an advanced energy device andthe modifications of the control parameters may include a clamppressure, an operational power level, an operational frequency, and atransducer signal amplitude.

As disclosed above, blood vessels may be detected under the surface of asurgical site base on the Doppler shift in light reflected by the bloodcells moving within the blood vessels.

Laser Doppler flowmetry may be used to visualize and characterized aflow of particles moving relative to an effectively stationarybackground. Thus, laser light scattered by moving particles, such asblood cells, may have a different wavelength than that of the originalilluminating laser source. In contrast, laser light scattered by theeffectively stationary background (for example, the vascular tissue) mayhave the same wavelength of that of the original illuminating lasersource. The change in wavelength of the scattered light from the bloodcells may reflect both the direction of the flow of the blood cellsrelative to the laser source as well as the blood cell velocity. Aspreviously disclosed, FIGS. 26A-C illustrate the change in wavelength oflight scattered from blood cells that may be moving away from (FIG. 26A)or towards (FIG. 26C) the laser light source.

In each of FIGS. 26A-C, the original illuminating light 2502 is depictedhaving a relative central wavelength of 0. It may be observed from FIG.26A that light scattered from blood cells moving away from the lasersource 2504 has a wavelength shifted by some amount 2506 to a greaterwavelength relative to that of the laser source (and is thus redshifted). It may also be observed from FIG. 24C that light scatteredfrom blood cells moving towards from the laser source 2508 has awavelength shifted by some amount 2510 to a shorter wavelength relativeto that of the laser source (and is thus blue shifted). The amount ofwavelength shift (for example 2506 or 2510) may be dependent on thevelocity of the motion of the blood cells. In some aspects, an amount ofa red shift (2506) of some blood cells may be about the same as theamount of blue shift (2510) of some other blood cells. Alternatively, anamount of a red shift (2506) of some blood cells may differ from theamount of blue shift (2510) of some other blood cells Thus, the velocityof the blood cells flowing away from the laser source as depicted inFIG. 24A may be less than the velocity of the blood cells flowingtowards the laser source as depicted in FIG. 26C based on the relativemagnitude of the wavelength shifts (2506 and 2510). In contrast, and asdepicted in FIG. 26B, light scattered from tissue not moving relative tothe laser light source (for example blood vessels 2512 or non-vasculartissue 2514) may not demonstrate any change in wavelength.

As previously disclosed, FIG. 27 depicts an aspect of instrumentation2530 that may be used to detect a Doppler shift in laser light scatteredfrom portions of a tissue 2540. Light 2534 originating from a laser 2532may pass through a beam splitter 2544. Some portion of the laser light2536 may be transmitted by the beam splitter 2544 and may illuminatetissue 2540. Another portion of the laser light may be reflected 2546 bythe beam splitter 2544 to impinge on a detector 2550. The lightback-scattered 2542 by the tissue 2540 may be directed by the beamsplitter 2544 and also impinge on the detector 2550. The combination ofthe light 2534 originating from the laser 2532 with the lightback-scattered 2542 by the tissue 2540 may result in an interferencepattern detected by the detector 2550. The interference pattern receivedby the detector 2550 may include interference fringes resulting from thecombination of the light 2534 originating from the laser 2532 and theDoppler shifted (and thus wavelength shifted) light back-scattered 2452from the tissue 2540.

It may be recognized that back-scattered light 2542 from the tissue 2540may also include back scattered light from boundary layers within thetissue 2540 and/or wavelength-specific light absorption by materialwithin the tissue 2540. As a result, the interference pattern observedat the detector 2550 may incorporate interference fringe features fromthese additional optical effects and may therefore confound thecalculation of the Doppler shift unless properly analyzed.

It may be recognized that light reflected from the tissue may alsoinclude back scattered light from boundary layers within the tissueand/or wavelength-specific light absorption by material within thetissue. As a result, the interference pattern observed at the detectormay incorporate fringe features that may confound the calculation of theDoppler shift unless properly analyzed.

As previously disclosed, FIG. 28 depicts some of these additionaloptical effects. It is well known that light traveling through a firstoptical medium having a first refractive index, n1, may be reflected atan interface with a second optical medium having a second refractiveindex, n2. The light transmitted through the second optical medium willhave a transmission angle relative to the interface that differs fromthe angle of the incident light based on a difference between therefractive indices n1 and n2 (Snell's Law). FIG. 26 illustrates theeffect of Snell's Law on light impinging on the surface of amulti-component tissue 2150, as may be presented in a surgical field.The multi-component tissue 2150 may be composed of an outer tissue layer2152 having a refractive index n1 and a buried tissue, such as a bloodvessel having a vessel wall 2156. The blood vessel wall 2156 may becharacterized by a refractive index n2. Blood may flow within the lumenof the blood vessel 2160. In some aspects, it may be important during asurgical procedure to determine the position of the blood vessel 2160below the surface 2154 of the outer tissue layer 2152 and tocharacterize the blood flow using Doppler shift techniques.

An incident laser light 2170 a may be used to probe for the blood vessel2160 and may be directed on the top surface 2154 of the outer tissuelayer 2152. A portion 2172 of the incident laser light 2170 a may bereflected at the top surface 2154. Another portion 2170 b of theincident laser light 2170 a may penetrate the outer tissue layer 2152.The reflected portion 2172 at the top surface 2154 of the outer tissuelayer 2152 has the same path length of the incident light 2170 a, andtherefore has the same wavelength and phase of the incident light 2170a. However, the portion 2170 b of light transmitted into the outertissue layer 2152 will have a transmission angle that differs from theincidence angle of the light impinging on the tissue surface because theouter tissue layer 2152 has an index of refraction n1 that differs fromthe index of refraction of air.

If the portion of light transmitted through the outer tissue layer 2152impinges on a second tissue surface 2158, for example of the bloodvessel wall 2156, some portion 2174 a,b of light will be reflected backtowards the source of the incident light 2170 a. The light thusreflected 2174 a at the interface between the outer tissue layer 2152and the blood vessel wall 2156 will have the same wavelength as theincident light 2170 a, but will be phase shifted due to the change inthe light path length. Projecting the light reflected 2174 a,b from theinterface between the outer tissue layer 2152 and the blood vessel wall2156 along with the incident light on the sensor, will produce aninterference pattern based on the phase difference between the two lightsources.

Further, a portion of the incident light 2170 c may be transmittedthrough the blood vessel wall 2156 and penetrate into the blood vessellumen 2160. This portion of the incident light 2170 c may interact withthe moving blood cells in the blood vessel lumen 2160 and may bereflected back 2176 a-c towards the source of the impinging light havinga wavelength Doppler shifted according to the velocity of the bloodcells, as disclosed above. The Doppler shifted light reflected 2176 a-cfrom the moving blood cells may be projected along with the incidentlight on the sensor, resulting in an interference pattern having afringe pattern based on the wavelength difference between the two lightsources.

In FIG. 28 , a light path 2178 is presented of light impinging on thered blood cells in the blood vessel lumen 2160 if there are no changesin refractive index between the emitted light and the light reflected bythe moving blood cells. In this example, only a Doppler shift in thereflected light wavelength can be detected. However, the light reflectedby the blood cells (2176 a-c) may incorporate phase changes due to thevariation in the tissue refractive indices in addition to the wavelengthchanges due to the Doppler Effect.

Thus, it may be understood that if the light sensor receives theincident light, the light reflected from one or more tissue interfaces(2172, and 2174 a,b) and the Doppler shifted light from the blood cells(2176 a-c), the interference pattern thus produced on the light sensormay include the effects due to the Doppler shift (change in wavelength)as well as the effects due to the change in refractive index within thetissue (change in phase). As a result, a Doppler analysis of the lightreflected by the tissue sample may produce erroneous results if theeffects due to changes in the refractive index within the sample are notcompensated for.

As previously disclosed, FIG. 29 illustrates an example of the effectson a Doppler analysis of light that impinge 2250 on a tissue sample todetermine the depth and location of an underlying blood vessel. If thereis no intervening tissue between the blood vessel and the tissuesurface, the interference pattern detected at the sensor may be dueprimarily to the change in wavelength reflected from the moving bloodcells. As a result, a spectrum 2252 derived from the interferencepattern may generally reflect only the Doppler shift of the blood cells.However, if there is intervening tissue between the blood vessel and thetissue surface, the interference pattern detected at the sensor may bedue to a combination of the change in wavelength reflected from themoving blood cells and the phase shift due to the refractive index ofthe intervening tissue. A spectrum 2254 derived from such aninterference pattern, may result in the calculation of the Doppler shiftthat is confounded due to the additional phase change in the reflectedlight. In some aspects, if information regarding the characteristics(thickness and refractive index) of the intervening tissue is known, theresulting spectrum 2256 may be corrected to provide a more accuratecalculation of the change in wavelength.

It may be recognized that the phase shift in the reflected light from atissue may provide additional information regarding underlying tissuestructures, regardless of Doppler effects.

FIG. 37 illustrates that the location and characteristics ofnon-vascular structures may be determined based on the phase differencebetween the incident light 2372 and the light reflected from the deeptissue structures (2374, 2376, 2378). As noted above, the penetrationdepth of light impinging on a tissue is dependent on the wavelength ofthe impinging illumination. Red laser light (having a wavelength in therange of about 635 nm to about 660 nm) may penetrate the tissue to adepth of about 1 mm. Green laser light (having a wavelength in the rangeof about 520 nm to about 532 nm) may penetrate the tissue to a depth ofabout 2-3 mm. Blue laser light (having a wavelength in the range ofabout 405 nm to about 445 nm) may penetrate the tissue to a depth ofabout 4 mm or greater. In one aspect, an interface 2381 a between twotissues differing in refractive index that is located less than or about1 mm below a tissue surface 2380 may reflect 2374 red, green, or bluelaser light. The phase of the reflected light 2374 may be compared tothe incident light 2372 and thus the difference in the refractive indexof the tissues at the interface 2381 a may be determined. In anotheraspect, an interface 2381 b between two tissues differing in refractiveindex that is located between 2 and 3 mm 2381 b below a tissue surface2380 may reflect 2376 green or blue laser light, but not red light. Thephase of the reflected light 2376 may be compared to the incident light2372 and thus the difference in the refractive index of the tissues atthe interface 2381 b may be determined. In yet another aspect, aninterface 2381 c between two tissues differing in refractive index thatis located between 3 and 4 mm 2381 c below a tissue surface 2380 mayreflect 2378 only blue laser light, but not red or green light. Thephase of the reflected light 2378 may be compared to the incident light2372 and thus the difference in the refractive index of the tissues atthe interface 2381 c may be determined.

A phase interference measure of a tissue illuminated by light havingdifferent wavelengths may therefore provide information regarding therelative indices of refraction of the reflecting tissue as well as thedepth of the tissue. The indices of refraction of the tissue may beassessed using the multiple laser sources and their intensity, andthereby relative indices of refraction may be calculated for the tissue.It is recognized that different tissues may have different refractiveindices. For example, the refractive index may be related to therelative composition of collagen and elastin in a tissue or the amountof hydration of the tissue. Therefore, a technique to measure relativetissue index of refraction may result in the identification of acomposition of the tissue.

In some aspects, smart surgical instruments include algorithms todetermine parameters associated with the function of the instruments.One non-limiting example of such parameters may be the pressure of ananvil against a tissue for a smart stapling device. The amount ofpressure of an anvil against a tissue may depend on the type andcomposition of the tissue. For example, less pressure may be required tostaple a highly compressive tissue, while a greater amount of pressuremay be required to stable a more non-compressive tissue. Anothernon-limiting example of a parameter associated with a smart surgicaldevice may include a rate of firing of an i-beam knife to cut thetissue. For example, a stiff tissue may require more force and a slowercutting rate than a less stiff tissue. Another non-limiting example ofsuch parameters may be the amount of current provided to an electrode ina smart cauterizing or RF sealing device. Tissue composition, such aspercent tissue hydration, may determine an amount of current necessaryto heat seal the tissue. Yet another non-limiting example of suchparameters may be the amount of power provided to an ultrasonictransducer of a smart ultrasound cutting device or the driving frequencyof the cutting device. A stiff tissue may require more power forcutting, and contact of the ultrasonic cutting tool with a stiff tissuemay shift the resonance frequency of the cutter.

It may be recognized that a tissue visualization system that canidentify tissue type and depth may provide such data to one or moresmart surgical devices. The identification and location data may then beused by the smart surgical devices to adjust one or more of theiroperating parameters thereby allowing them to optimize theirmanipulation of the tissue. It may be understood that an optical methodto characterize a type of tissue may permit automation of the operatingparameters of the smart surgical devices. Such automation of theoperation of smart surgical instruments may be preferable to relying onhuman estimation to determine the operational parameters of theinstruments.

In one aspect, Optical Coherence Tomography (OCT) is a technique thatcan visual subsurface tissue structures based on the phase differencebetween an illuminating light source, and light reflected fromstructures located within the tissue. FIG. 38 depicts schematically oneexample of instrumentation 2470 for Optical Coherence Tomography. InFIG. 38 , a laser source 2472 may emit light 2482 according to anyoptical wavelength of interest (red, green, blue, infrared, orultraviolet). The light 2482 may be directed to a beam splitter 2486.The beam splitter 2486 directs one portion of the light 2488 to a tissuesample 2480. The beam splitter 2486 may also direct a portion of thelight 2492 to a stationary reference mirror 2494. The light reflectedfrom the tissue sample 2480 and from the stationary mirror 2494 may berecombined 2498 at the beam splitter 2486 and directed to a detector2496. The phase difference between the light from the reference mirror2494 and from the tissue sample 2480 may be detected at the detector2496 as an interference pattern. Appropriate computing devices may thencalculate phase information from the interference pattern. Additionalcomputation may then provide information regarding structures below thesurface of the tissue sample. Additional depth information may also beobtained by comparing the interference patterns generated from thesample when illuminated at different wavelengths of laser light.

As disclosed above, depth information regarding subsurface tissuestructures may be ascertained from a combination of laser lightwavelength and the phase of light reflected from a deep tissuestructure. Additionally, local tissue surface inhomogeneity may beascertained by comparing the phase as well as amplitude difference oflight reflected from different portions of the same sub-surface tissues.Measurements of a difference in the tissue surface properties at adefined location compared to those at a neighboring location may beindicative of adhesions, disorganization of the tissue layers,infection, or a neoplasm in the tissue being probed.

FIG. 39 illustrates this effect. The surface characteristics of a tissuedetermine the angle of reflection of light impinging on the surface. Asmooth surface 2551 a reflects the light essentially with the samespread 2544 as the light impinging on the surface 2542 (specularreflection). Consequently, the amount of light received by a lightdetector having a known fixed aperture may effectively receive theentire amount of light reflected 2544 from the smooth surface 2551 a.However, increased surface roughness at a tissue surface may result inan increase spread in the reflected light with respect to the incidentlight (diffuse reflection).

Some amount of the reflected light 2546 from a tissue surface havingsome amount of surface irregularities 2551 b will fall outside the fixedaperture of the light detector due to the increased spread of thereflected light 2546. As a result, the light detector will detect lesslight (shown in FIG. 39 as a decrease in the amplitude of the reflectedlight signal 2546). It may be understood that the amount of reflectedlight spread will increase as the surface roughness of a tissueincreases. Thus, as depicted in FIG. 39 , the amplitude of lightreflected 2548 from a surface 2551 c having significant surfaceroughness may have a smaller amplitude than the light reflected 2544from a smooth surface 2551 a, or light reflected 2546 form a surfacehaving only a moderate amount of surface roughness 2551 b. Therefore, insome aspects, a single laser source may be used to investigate thequality of a tissue surface or subsurface by comparing the opticalproperties of reflected light from the tissue with the opticalproperties of reflected light from adjacent surfaces.

In other aspects, light from multiple laser sources (for example, lasersemitting light having different central wavelengths) may be usedsequentially to probe tissue surface characteristics at a variety ofdepths below the surface 2550. As disclosed above (with reference toFIG. 37 ), the absorbance profile of a laser light in a tissue isdependent on the central wavelength of the laser light. Laser lighthaving a shorter (more blue) central wavelength can penetrate tissuedeeper than laser light having a longer (more red) central wavelength.Therefore, measurements related to light diffuse reflection made atdifferent light wavelengths can indicate both an amount of surfaceroughness as well as the depth of the surface being measured.

FIG. 40 illustrates one method of displaying image processing datarelated to a combination of tissue visualization modalities. Data usedin the display may be derived from image phase data related to tissuelayer composition, image intensity (amplitude) data related to tissuesurface features, and image wavelength data related to tissue mobility(such as blood cell transport) as well as tissue depth. As one example,light emitted by a laser in the blue optical region 2562 may impinge onblood flowing at a depth of about 4 mm below the surface of the tissue.The reflected light 2564 may be red shifted due to the Doppler effect ofthe blood flow. As a result, information may be obtained regarding theexistence of a blood vessel and its depth below the surface.

In another example, a layer of tissue may lie at a depth of about 2-3 mmbelow the surface of the surgical site. This tissue may include surfaceirregularities indicative of scarring or other pathologies. Emitted redlight 2572 may not penetrate to the 2-3 mm depth, so consequently, thereflected red light 2580 may have about the same amplitude of theemitted red light 2572 because it is unable to probe structures morethan 1 mm below the top surface of the surgical site. However, greenlight reflected from the tissue 2578 may reveal the existence of thesurface irregularities at that depth in that the amplitude of thereflected green light 2578 may be less than the amplitude of the emittedgreen light 2570. Similarly, blue light reflected from the tissue 2574may reveal the existence of the surface irregularities at that depth inthat the amplitude of the reflected blue light 2574 may be less than theamplitude of the emitted blue light 2562. In one example of an imageprocessing step, the image 2582 may be smoothed using a moving windowfilter 2584 to reduce inter-pixel noise as well as reduce small localtissue anomalies 2586 that may hide more important features 2588.

FIGS. 41A-C illustrate several aspects of displays that may be providedto a surgeon for a visual identification of surface and sub-surfacestructures of a tissue in a surgical site. FIG. 41A may represent asurface map of the surgical site with color coding to indicatestructures located at varying depths below the surface of the surgicalsite. FIG. 41B depicts an example of one of several horizontal slicesthrough the tissue at varying depths, which may be color coded toindicate depth and further include data associated with differences intissue surface anomalies (for example, as displayed in a 3D bar graph).FIG. 41C depicts yet another visual display in which surfaceirregularities as well as Doppler shift flowmetry data may indicatesub-surface vascular structures as well as tissue surfacecharacteristics.

FIG. 42 is a flow chart 2950 of a method for providing informationrelated to a characteristic of a tissue to a smart surgical instrument.An image acquisition system may illuminate 2960 a tissue with a firstlight beam having a first central frequency and receive 2962 a firstreflected light from the tissue illuminated by the first light beam. Theimage acquisition system may then calculate 2964 a first tissue surfacecharacteristic at a first depth based on the first emitted light beamand the first reflected light from the tissue. The image acquisitionsystem may then illuminate 2966 the tissue with a second light beamhaving a second central frequency and receive 2968 a second reflectedlight from the tissue illuminated by the second light beam. The imageacquisition system may then calculate 2970 a second tissue surfacecharacteristic at a second depth based on the second emitted light beamand the second reflected light from the tissue. Tissue features that mayinclude a tissue type, a tissue composition, and a tissue surfaceroughness metric may be determined from the first central lightfrequency, the second central light frequency, the first reflected lightfrom the tissue, and the second reflected light from the tissue. Thetissue characteristic may be used to calculate 2972 one or moreparameters related to the function of a smart surgical instrument suchas jaw pressure, power to effect tissue cauterization, or currentamplitude and/or frequency to drive a piezoelectric actuator to cut atissue. In some additional examples, the parameter may be transmitted2974 either directly or indirectly to the smart surgical instrumentwhich may modify its operating characteristics in response to the tissuebeing manipulated.

Multifocal Minimally Invasive Camera

In a minimally invasive procedure, e.g., laparoscopic, a surgeon mayvisualize the surgical site using imaging instruments including a lightsource and a camera. The imaging instruments may allow the surgeon tovisualize the end effector of a surgical device during the procedure.However, the surgeon may need to visualize tissue away from the endeffector to prevent unintended damage during the surgery. Such distanttissue may lie outside the field of view of the camera system whenfocused on the end effector. The imaging instrument may be moved inorder to change the field of view of the camera, but it may be difficultto return the camera system back to its original position after beingmoved.

The surgeon may attempt to move the imaging system within the surgicalsite to visualize different portions of the site during the procedure.Repositioning of the imaging system is time consuming and the surgeon isnot guaranteed to visualize the same field of view of the surgical sitewhen the imaging system is returned to its original location.

It is therefore desirable to have a medical imaging visualization systemthat can provide multiple fields of view of the surgical site withoutthe need to reposition the visualization system. Medical imaging devicesinclude, without limitation, laparoscopes, endoscopes, thoracoscopes,and the like, as described herein. In some aspects, a single displaysystem may display each of the multiple fields of view of the surgicalsite at about the same time. The display of each of the multiple fieldsof view may be independently updated depending on a display controlsystem composed of one or more hardware modules, one or more softwaremodules, one or more firmware modules, or any combination orcombinations thereof.

Some aspects of the present disclosure further provide for a controlcircuit configured to control the illumination of a surgical site usingone or more illumination sources such as laser light sources and toreceive imaging data from one or more image sensors. In some aspects,the control circuit may be configured to control the operation of one ormore light sensor modules to adjust a field of view. In some aspects,the present disclosure provides for a non-transitory computer readablemedium storing computer readable instructions that, when executed, causea device to adjust one or more components of the one or more lightsensor modules and to process an image from each of the one or morelight sensor modules.

An aspect of a minimally invasive image acquisition system may comprisea plurality of illumination sources wherein each illumination source isconfigured to emit light having a specified central wavelength, a firstlight sensing element having a first field of view and configured toreceive illumination reflected from a first portion of the surgical sitewhen the first portion of the surgical site is illuminated by at leastone of the plurality of illumination sources, a second light sensingelement having a second field of view and configured to receiveillumination reflected from a second portion of the surgical site whenthe second portion of the surgical site is illuminated by at least oneof the plurality of illumination sources, wherein the second field ofview overlaps at least a portion of the first field of view; and acomputing system.

The computing system may be configured to receive data from the firstlight sensing element, receive data from the second light sensingelement, compute imaging data based on the data received from the firstlight sensing element and the data received from the second lightsensing element, and transmit the imaging data for receipt by a displaysystem.

A variety of surgical visualization systems have been disclosed above.Such systems provide for visualizing tissue and sub-tissue structuresthat may be encountered during one or more surgical procedures.Non-limiting examples of such systems may include: systems to determinethe location and depth of subsurface vascular tissue such as veins andarteries; systems to determine an amount of blood flowing through thesubsurface vascular tissue; systems to determine the depth ofnon-vascular tissue structures; systems to characterize the compositionof such non-vascular tissue structures; and systems to characterize oneor more surface characteristics of such tissue structures.

It may be recognized that a single surgical visualization system mayincorporate components of any one or more of these visualizationmodalities. FIGS. 22A-D depict some examples of such a surgicalvisualization system 2108.

As disclosed above, in one non-limiting aspect, a surgical visualizationsystem 2108 may include an imaging control unit 2002 and a hand unit2020. The hand unit 2020 may include a body 2021, a camera scope cable2015 attached to the body 2021, and an elongated camera probe 2024. Theelongated camera probe 2024 may also terminate at its distal end with atleast one window. In some non-limiting examples, a light sensor 2030 maybe incorporated in the hand unit 2020, for example either in the body ofthe hand unit 2032 b, or at a distal end 2032 a of the elongated cameraprobe, as depicted in FIG. 22C. The light sensor 2030 may be fabricatedusing a CMOS sensor array or a CCD sensor array. As illustrated in FIG.23C, a typical CMOS or CCD sensor array may generate an RGB(red-green-blue) image from light impinging on a mosaic of sensorelements, each sensor element having one of a red, green, or blueoptical filter.

Alternatively, the illumination of the surgical site may be cycled amongvisible illumination sources as depicted in FIG. 30D. In some example,the illumination sources may include any one or more of a red laser 2360a, a green laser 2360 b, or a blue laser 2360 c. In some non-limitingexamples, a red laser 2360 a light source may source illumination havinga peak wavelength that may range between 635 nm and 660 nm, inclusive.Non-limiting examples of a red laser peak wavelength may include about635 nm, about 640 nm, about 645 nm, about 650 nm, about 655 nm, about660 nm, or any value or range of values therebetween. In somenon-limiting examples, a green laser 2360 b light source may sourceillumination having a peak wavelength that may range between 520 nm and532 nm, inclusive. Non-limiting examples of a red laser peak wavelengthmay include about 520 nm, about 522 nm, about 524 nm, about 526 nm,about 528 nm, about 530 nm, about 532 nm, or any value or range ofvalues therebetween. In some non-limiting examples, the blue laser 2360c light source may source illumination having a peak wavelength that mayrange between 405 nm and 445 nm, inclusive. Non-limiting examples of ablue laser peak wavelength may include about 405 nm, about 410 nm, about415 nm, about 420 nm, about 425 nm, about 430 nm, about 435 nm, about440 nm, about 445 nm, or any value or range of values therebetween.

Additionally, illumination of the surgical site may be cycled to includenon-visible illumination sources that may supply infra red orultraviolet illumination. In some non-limiting examples, an infra redlaser light source may source illumination having a peak wavelength thatmay range between 750 nm and 3000 nm, inclusive. Non-limiting examplesof an infra red laser peak wavelength may include about 750 nm, about1000 nm, about 1250 nm, about 1500 nm, about 1750 nm, about 2000 nm,about 2250 nm, about 2500 nm, about 2750 nm, 3000 nm, or any value orrange of values therebetween. In some non-limiting examples, anultraviolet laser light source may source illumination having a peakwavelength that may range between 200 nm and 360 nm, inclusive.Non-limiting examples of an ultraviolet laser peak wavelength mayinclude about 200 nm, about 220 nm, about 240 nm, about 260 nm, about280 nm, about 300 nm, about 320 nm, about 340 nm, about 360 nm, or anyvalue or range of values therebetween.

The outputs of the sensor array under the different illuminationwavelengths may be combined to form the RGB image, for example, if theillumination cycle time is sufficiently fast and the laser light is inthe visible range. FIGS. 43A and 43B illustrate a multi-pixel lightsensor receiving by light reflected by a tissue illuminated, forexample, by sequential exposure to red, green, blue, infra red, (FIG.43A) or red, green, blue, and ultraviolet laser light sources (FIG.43B).

FIG. 44A depicts the distal end of a flexible elongated camera probe2120 having a flexible camera probe shaft 2122 and a single light sensormodule 2124 disposed at the distal end 2123 of the flexible camera probeshaft 2122. In some non-limiting examples, the flexible camera probeshaft 2122 may have an outer diameter of about 5 mm. The outer diameterof the flexible camera probe shaft 2122 may depend on geometric factorsthat may include, without limitation, the amount of allowable bend inthe shaft at the distal end 2123. As depicted in FIG. 44A, the distalend 2123 of the flexible camera probe shaft 2122 may bend about 90° withrespect to a longitudinal axis of an un-bent portion of the flexiblecamera probe shaft 2122 located at a proximal end of the elongatedcamera probe 2120. It may be recognized that the distal end 2123 of theflexible camera probe shaft 2122 may bend any appropriate amount as maybe required for its function. Thus, as non-limiting examples, the distalend 2123 of the flexible camera probe shaft 2122 may bend any amountbetween about 0° and about 90°. Non-limiting examples of the bend angleof the distal end 2123 of the flexible camera probe shaft 2122 mayinclude about 0°, about 10°, about 20°, about 30°, about 40°, about 50°,about 60°, about 70°, about 80°, about 90°, or any value or range ofvalues therebetween. In some examples, the bend angle of the distal end2123 of the flexible camera probe shaft 2122 may be set by a surgeon orother health care professional prior to or during a surgical procedure.In some other example, the bend angle of the distal end 2123 of theflexible camera probe shaft 2122 may be a fixed angle set at amanufacturing site.

The single light sensor module 2124 may receive light reflected from thetissue when illuminated by light emitted by one or more illuminationsources 2126 disposed at the distal end of the elongated camera probe.In some examples, the light sensor module 2124 may be a 4 mm sensormodule such as 4 mm mount 2136 b, as depicted in FIG. 22D. It may berecognized that the light sensor module 2124 may have any appropriatesize for its intended function. Thus, the light sensor module 2124 mayinclude a 5.5 mm mount 2136 a, a 2.7 mm mount 2136 c, or a 2 mm mount2136 d as depicted in FIG. 22D.

It may be recognized that the one or more illumination sources 2126 mayinclude any number of illumination sources 2126 including, withoutlimitation, one illumination source, two illumination sources, threeillumination sources, four illumination sources, or more than fourillumination sources. It may be further understood that eachillumination source may source illumination having any centralwavelength including a central red illumination wavelength, a centralgreen illumination wavelength, a central blue illumination wavelength, acentral infrared illumination wavelength, a central ultravioletillumination wavelength, or any other wavelength. In some examples, theone or more illumination sources 2126 may include a white light source,which may illuminate tissue with light having wavelengths that may spanthe range of optical white light from about 390 nm to about 700 nm.

FIG. 44B depicts the distal end 2133 of an alternative elongated cameraprobe 2130 having multiple light sensor modules, for example the twolight sensor modules 2134 a,b, each disposed at the distal end 2133 ofthe elongated camera probe 2130. In some non-limiting examples, thealternative elongated camera probe 2130 may have an outer diameter ofabout 7 mm. In some examples, the light sensor modules 2134 a,b may eachcomprise a 4 mm sensor module, similar to light sensor module 2124 inFIG. 44A. Alternatively, each of the light sensor modules 2134 a,b maycomprise a 5.5 mm light sensor module, a 2.7 mm light sensor module, ora 2 mm light sensor module as depicted in FIG. 22D. In some examples,both light sensor modules 2134 a,b may have the same size. In someexamples, the light sensor modules 2134 a,b may have different sizes. Asone non-limiting example, an alternative elongated camera probe 2130 mayhave a first 4 mm light sensor and two additional 2 mm light sensors. Insome aspects, a visualization system may combine the optical outputsfrom the multiple light sensor modules 2134 a,b to form a 3D or quasi-3Dimage of the surgical site. In some other aspects, the outputs of themultiple light sensor modules 2134 a,b may be combined in such a manneras to enhance the optical resolution of the surgical site, which may notbe otherwise practical with only a single light sensor module.

Each of the multiple light sensor modules 2134 a,b may receive lightreflected from the tissue when illuminated by light emitted by one ormore illumination sources 2136 a,b disposed at the distal end 2133 ofthe alternative elongated camera probe 2130. In some non-limitingexamples, the light emitted by all of the illumination sources 2136 a,bmay be derived from the same light source (such as a laser). In othernon-limiting examples, the illumination sources 2136 a surrounding afirst light sensor module 2134 a may emit light at a first wavelengthand the illumination sources 2136 b surrounding a second light sensormodule 2134 b may emit light at a second wavelength. It may be furtherunderstood that each illumination source 2136 a,b may sourceillumination having any central wavelength including a central redillumination wavelength, a central green illumination wavelength, acentral blue illumination wavelength, a central infrared illuminationwavelength, a central ultraviolet illumination wavelength, or any otherwavelength. In some examples, the one or more illumination sources 2136a,b may include a white light source, which may illuminate tissue withlight having wavelengths that may span the range of optical white lightfrom about 390 nm to about 700 nm.

In some additional aspects, the distal end 2133 of the alternativeelongated camera probe 2130 may include one or more working channels2138. Such working channels 2138 may be in fluid communication with anaspiration port of a device to aspirate material from the surgical site,thereby permitting the removal of material that may potentially obscurethe field of view of the light sensor modules 2134 a,b. Alternatively,such working channels 2138 may be in fluid communication with an fluidsource port of a device to provide a fluid to the surgical site, toflush debris or material away from the surgical site. Such fluids may beused to clear material from the field of view of the light sensormodules 2134 a,b.

FIG. 44C depicts a perspective view of an aspect of a monolithic sensor2160 having a plurality of pixel arrays for producing a threedimensional image in accordance with the teachings and principles of thedisclosure. Such an implementation may be desirable for threedimensional image capture, wherein the two pixel arrays 2162 and 2164may be offset during use. In another implementation, a first pixel array2162 and a second pixel array 2164 may be dedicated to receiving apredetermined range of wave lengths of electromagnetic radiation,wherein the first pixel array 2162 is dedicated to a different range ofwave length electromagnetic radiation than the second pixel array 2164.

Additional disclosures regarding a dual sensor array may be found inU.S. Patent Application Publication No. 2014/0267655, titled SUPERRESOLUTION AND COLOR MOTION ARTIFACT CORRECTION IN A PULSED COLORIMAGING SYSTEM, filed on Mar. 14, 2014, which issued on May 2, 2017 asU.S. Pat. No. 9,641,815, the contents thereof being incorporated byreference herein in its entirety and for all purposes.

In some aspects, a light sensor module may comprise a multi-pixel lightsensor such as a CMOS array in addition to one or more additionaloptical elements such as a lens, a reticle, and a filter.

In some alternative aspects, the one or more light sensors may belocated within the body 2021 of the hand unit 2020. Light reflected fromthe tissue may be acquired at a light receiving surface of one or moreoptical fibers at the distal end of the elongated camera probe 2024. Theone or more optical fibers may conduct the light from the distal end ofthe elongated camera probe 2024 to the one or more light sensors, or toadditional optical elements housed in the body of the hand unit 2020 orin the imaging control unit 2002. The additional optical elements mayinclude, without limitation, one or more dichroic mirrors, one or morereference mirrors, one or more moving mirrors, and one or more beamsplitters and/or combiners, and one or more optical shutters. In suchalternative aspects, the light sensor module may include any one or moreof a lens, a reticle and a filter, disposed at the distal end of theelongated camera probe 2024.

Images obtained from each of the multiple light sensors for example 2134a,b may be combined or processed in several different manners, either incombination or separately, and then displayed in a manner to allow asurgeon to visualize different aspects of the surgical site.

In one non-limiting example, each light sensor may have an independentfield of view. In some additional examples, the field of view of a firstlight sensor may partially or completely overlap the field of view of asecond light sensor.

As disclosed above, an imaging system may include a hand unit 2020having an elongated camera probe 2024 with one or more light sensormodules 2124, 2134 a,b disposed at its distal end 2123, 2133. As anexample, the elongated camera probe 2024 may have two light sensormodules 2134 a,b, although it may be recognized that there may be three,four, five, or more light sensor modules at the distal end of theelongated camera probe 2024. Although FIGS. 45 and 46A-D depict examplesof the distal end of an elongated camera probe having two light sensormodules, it may be recognized that the description of the operation ofthe light sensor modules is not limited to solely two light sensormodules. As depicted in FIGS. 45, and 46A-D, the light sensor modulesmay include an image sensor, such as a CCD or CMOS sensor that may becomposed of an array of light sensing elements (pixels). The lightsensor modules may also include additional optical elements, such aslenses. Each lens may be adapted to provide a field of view for thelight sensor of the respective light sensor module.

FIG. 45 depicts a generalized view of a distal end 2143 of an elongatedcamera probe having multiple light sensor modules 2144 a,b. Each lightsensor module 2144 a,b may be composed of a CCD or CMOS sensor and oneor more optical elements such as filters, lenses, shutters, and similar.In some aspects, the components of the light sensor modules 2144 a,b maybe fixed within the elongated camera probe. In some other aspects, oneor more of the components of the light sensor modules 2144 a,b may beadjustable. For example, the CCD or CMOS sensor of a light sensor module2144 a,b may be mounted on a movable mount to permit automatedadjustment of the center 2145 a,b of a field of view 2147 a,b of the CCDor CMOS sensor. In some other aspects, the CCD or CMOS sensor may befixed, but a lens in each light sensor modules 2144 a,b may beadjustable to change the focus. In some aspects, the light sensormodules 2144 a,b may include adjustable irises to permit changes in thevisual aperture of the sensor modules 2144 a,b.

As depicted in FIG. 45 , each of the sensor modules 2144 a,b may have afield of view 2147 a,b having an acceptance angle. As depicted in FIG.45 , the acceptance angle for each sensor modules 2144 a,b may have anacceptance angle of greater than 90°. In some examples, the acceptanceangle may be about 100°. In some examples, the acceptance angle may beabout 120°. In some examples, if the sensor modules 2144 a,b have anacceptance angle of greater than 90° (for example, 100°), the fields ofview 2147 a and 2147 b may form an overlap region 2150 a,b. In someaspects, an optical field of view having an acceptance angle of 100° orgreater may be called a “fish-eyed” field of view. A visualizationsystem control system associated with such an elongated camera probe mayinclude computer readable instructions that may permit the display ofthe overlap region 2150 a,b in such a manner so that the extremecurvature of the overlapping fish-eyed fields of view is corrected, anda sharpened and flattened image may be displayed. In FIG. 45 , theoverlap region 2150 a may represent a region wherein the overlappingfields of view 2147 a,b of the sensor modules 2144 a,b have theirrespective centers 2145 a,b directed in a forward direction. However, ifany one or more components of the sensor modules 2144 a,b is adjustable,it may be recognized that the overlap region 2150 b may be directed toany attainable angle within the fields of view 2147 a,b of the sensormodules 2144 a,b.

FIGS. 46A-D depict a variety of examples of an elongated light probehaving two light sensor modules 2144 a,b with a variety of fields ofview. The elongated light probe may be directed to visualize a surface2152 of a surgical site.

In FIG. 46A, the first light sensor module 2144 a has a first sensorfield of view 2147 a of a tissue surface 2154 a, and the second lightsensor module 2144 b has a second sensor field of view 2147 b of atissue surface 2154 b. As depicted in FIG. 46A, the first field of view2147 a and the second field of view 2147 b have approximately the sameangle of view. Additionally, the first sensor field of view 2147 a isadjacent to but does not overlap the second sensor field of view 2147 b.The image received by the first light sensor module 2144 a may bedisplayed separately from the image received by the second light sensormodule 2144 b, or the images may be combined to form a single image. Insome non-limiting examples, the angle of view of a lens associated withthe first light sensor module 2144 a and the angle of view of a lensassociated with the second light sensor module 2144 b may be somewhatnarrow, and image distortion may not be great at the periphery of theirrespective images. Therefore, the images may be easily combined edge toedge.

As depicted in FIG. 46B, the first field of view 2147 a and the secondfield of view 2147 b have approximately the same angular field of view,and the first sensor field of view 2147 a overlaps completely the secondsensor field of view 2147 b. This may result in a first sensor field ofview 2147 a of a tissue surface 2154 a being identical to the view of atissue surface 2154 b as obtained by the second light sensor module 2144b from the second sensor field 2147 b of view. This configuration may beuseful for applications in which the image from the first light sensormodule 2144 a may be processed differently than the image from thesecond light sensor module 2144 b. The information in the first imagemay complement the information in the second image and refer to the sameportion of tissue.

As depicted in FIG. 46C, the first field of view 2147 a and the secondfield of view 2147 b have approximately the same angular field of view,and the first sensor field of view 2147 a partially overlaps the secondsensor field of view 2147 b. In some non-limiting examples, a lensassociated with the first light sensor module 2144 a and a lensassociated with the second light sensor module 2144 b may be wide anglelenses. These lenses may permit the visualization of a wider field ofview than that depicted in FIG. 46A. Wide angle lenses are known to havesignificant optical distortion at their periphery. Appropriate imageprocessing of the images obtained by the first light sensor module 2144a and the second light sensor module 2144 b may permit the formation ofa combined image in which the central portion of the combined image iscorrected for any distortion induced by either the first lens or thesecond lens. It may be understood that a portion of the first sensorfield of view 2147 a of a tissue surface 2154 a may thus have somedistortion due to the wide angle nature of a lens associated with thefirst light sensor module 2144 a and a portion of the second sensorfield of view 2147 b of a tissue surface 2154 b may thus have somedistortion due to the wide angle nature of a lens associated with thesecond light sensor module 2144 b. However, a portion of the tissueviewed in the overlap region 2150′ of the two light sensor modules 2144a,b may be corrected for any distortion induced by either of the lightsensor modules 2144 a,b. The configuration depicted in FIG. 46C may beuseful for applications in which it is desired to have a wide field ofview of the tissue around a portion of a surgical instrument during asurgical procedure. In some examples, lenses associated with each lightsensor module 2144 a,b may be independently controllable, therebycontrolling the location of the overlap region 2150′ of view within thecombined image.

As depicted in FIG. 46D, the first light sensor module 2144 a may have afirst angular field of view 2147 a that is wider than the second angularfield of view 2147 b of the second light sensor module 2144 b. In somenon-limiting examples, the second sensor field of view 2147 b may betotally disposed within the first sensor field of view 2147 a. Inalternative examples, the second sensor field of view may lie outside ofor tangent to the wide angle field of view 2147 a of the first sensor2144 a. A display system that may use the configuration depicted in FIG.46D may display a wide angle portion of tissue 2154 a imaged by thefirst sensor module 2144 a along with a magnified second portion oftissue 2154 b imaged by the second sensor module 2144 b and located inan overlap region 2150″ of the first field of view 2147 a and the secondfield of view 2147 b. This configuration may be useful to present asurgeon with a close-up image of tissue proximate to a surgicalinstrument (for example, imbedded in the second portion of tissue 2154b) and a wide-field image of the tissue surrounding the immediatevicinity of the medical instrument (for example, the proximal firstportion of tissue 2154 a). In some non-limiting examples, the imagepresented by the narrower second field of view 2147 b of the secondlight sensor module 2144 b may be a surface image of the surgical site.In some additional examples, the image presented in the first wide fieldview 2147 a of the first light sensor module 2144 a may include adisplay based on a hyperspectral analysis of the tissue visualized inthe wide field view.

FIGS. 47A-C illustrate an example of the use of an imaging systemincorporating the features disclosed in FIG. 46D. FIG. 47A illustratesschematically a proximal view 2170 at the distal end of the elongatedcamera probe depicting the light sensor arrays 2172 a,b of the two lightsensor modules 2174 a,b. A first light sensor module 2174 a may includea wide angle lens, and the second light sensor module 2174 b may includea narrow angle lens. In some aspects, the second light sensor module2174 b may have a narrow aperture lens. In other aspects, the secondlight sensor module 2174 b may have a magnifying lens. The tissue may beilluminated by the illumination sources disposed at the distal end ofthe elongated camera probe. The light sensor arrays 2172′ (either lightsensor array 2172 a or 2172 b, or both 2172 a and 2172 b) may receivethe light reflected from the tissue upon illumination. The tissue may beilluminated by light from a red laser source, a green laser source, ablue laser source, an infra red laser source, and/or an ultravioletlaser source. In some aspects, the light sensor arrays 2172′ maysequentially receive the red laser light 2175 a, green laser light 2175b, blue laser light 2175 c, infrared laser light 2175 d, and theultra-violet laser light 2175 e. The tissue may be illuminated by anycombination of such laser sources simultaneously, as depicted in FIGS.23E and 23F. Alternatively, the illuminating light may be cycled amongany combination of such laser sources, as depicted for example in FIG.23D, and FIGS. 43A and 43B.

FIG. 47B schematically depicts a portion of lung tissue 2180 which maycontain a tumor 2182. The tumor 2182 may be in communication with bloodvessels including one or more veins 2184 and/or arteries 2186. In somesurgical procedures, the blood vessels (veins 2184 and arteries 2186)associated with the tumor 2182 may require resection and/orcauterization prior to the removal of the tumor.

FIG. 47C illustrates the use of a dual imaging system as disclosed abovewith respect to FIG. 47A. The first light sensor module 2174 a mayacquire a wide angle image of the tissue surrounding a blood vessel 2187to be severed with a surgical knife 2190. The wide angle image maypermit the surgeon to verify the blood vessel to be severed 2187. Inaddition, the second light sensor module 2174 b may acquire a narrowangle image of the specific blood vessel 2187 to be manipulated. Thenarrow angle image may show the surgeon the progress of the manipulationof the blood vessel 2187. In this manner, the surgeon is presented withthe image of the vascular tissue to be manipulated as well as itsenvirons to assure that the correct blood vessel is being manipulated.

FIGS. 48A and 48B depict another example of the use of a dual imagingsystem. FIG. 48A depicts a primary surgical display providing an imageof a section of a surgical site. The primary surgical display may depicta wide view image 2800 of a section of intestine 2802 along with itsvasculature 2804. The wide view image 2800 may include a portion of thesurgical field 2809 that may be separately displayed as a magnified view2810 in a secondary surgical display (FIG. 48B). As disclosed above withrespect to surgery to remove a tumor from a lung (FIGS. 47A-C), it maybe necessary to dissect blood vessels supplying a tumor 2806 beforeremoving the cancerous tissue. The vasculature 2804 supplying theintestines 2802 is complex and highly ramified. It may necessary todetermine which blood vessels supply the tumor 2806 and to identifyblood vessels supplying blood to healthy intestinal tissue. The wideview image 2800 permits a surgeon to determine which blood vessel maysupply the tumor 2806. The surgeon may then test a blood vessel using aclamping device 2812 to determine if the blood vessel supplies the tumor2806 or not.

FIG. 48B depicts a secondary surgical display that may only display anarrow magnified view image 2810 of one portion of the surgical field2809. The narrow magnified view image 2810 may present a close-up viewof the vascular tree 2814 so that the surgeon can focus on dissectingonly the blood vessel of interest 2815. For resecting the blood vesselof interest 2815, a surgeon may use a smart RF cautery device 2816. Itmay be understood that any image obtained by the visualization systemmay include not only images of the tissue in the surgical site but alsoimages of the surgical instruments inserted therein. In some aspects,such a surgical display (either the primary display in FIG. 48A or thesecondary display in FIG. 48B) may also include indicia 2817 related tofunctions or settings of any surgical device used during the surgicalprocedure. For example, the indicia 2817 may include a power setting ofthe smart RF cautery device 2816. In some aspects, such smart medicaldevices may transmit data related to their operating parameters to thevisualization system to incorporate in display data to be transmitted toone or more display devices.

FIGS. 49A-C illustrate examples of a sequence of surgical steps for theremoval of an intestinal/colon tumor and which may benefit from the useof multi-image analysis at the surgical site. FIG. 49A depicts a portionof the surgical site, including the intestines 2932 and the ramifiedvasculature 2934 supplying blood and nutrients to the intestines 2932.The intestines 2932 may have a tumor 2936 surrounded by a tumor margin2937. A first light sensor module of a visualization system may have awide field of view 2930, and it may provide imaging data of the widefield of view 2930 to a display system. A second light sensor module ofthe visualization system may have a narrow or standard field of view2940, and it may provide imaging data of the narrow field of view 2940to the display system. In some aspects, the wide field image and thenarrow field image may be displayed by the same display device. Inanother aspect, the wide field image and the narrow field image may bedisplayed by separate display devices.

During the surgical procedure, it my be important to remove not just thetumor 2936 but the margin 2937 surrounding it to assure complete removalof the tumor. A wide angle field of view 2930 may be used to image boththe vasculature 2934 as well as the section of the intestines 2932surrounding the tumor 2936 and the margin 2637. As noted above, thevasculature feeding the tumor 2936 and the margin 2637 should beremoved, but the vasculature feeding the surrounding intestinal tissuemust be preserved to provide oxygen and nutrients to the surroundingtissue. Transection of the vasculature feeding the surrounding colontissue will remove oxygen and nutrients from the tissue, leading tonecrosis. In some examples, laser Doppler imaging of the tissuevisualized in the wide angle field 2630 may be analyzed to provide aspeckle contrast analysis 2933, indicating the blood flow within theintestinal tissue.

FIG. 49B illustrates a step during the surgical procedure. The surgeonmay be uncertain which part of the vascular tree supplies blood to thetumor 2936. The surgeon may test a blood vessel 2944 to determine if itfeeds the tumor 2936 or the healthy tissue. The surgeon may clamp ablood vessel 2944 with a clamping device 2812 and determine the sectionof the intestinal tissue 2943 that is no longer perfused by means of thespeckle contrast analysis. The narrow field of view 2940 displayed on animaging device may assist the surgeon in the close-up and detailed workrequired to visualize the single blood vessel 2944 to be tested. Whenthe suspected blood vessel 2944 is clamped, a portion of the intestinaltissue 2943 is determined to lack perfusion based on the Doppler imagingspeckle contras analysis. As depicted in FIG. 29B, the suspected bloodvessel 2944 does not supply blood to the tumor 2935 or the tumor margin2937, and therefore is recognized as a blood vessel to be spared duringthe surgical procedure.

FIG. 49C depicts a following stage of the surgical procedure. In stage,a supply blood vessel 2984 has been identified to supply blood to themargin 2937 of the tumor. When this supply blood vessel 2984 has beensevered, blood is no longer supplied to a section of the intestine 2987that may include at least a portion of the margin 2937 of the tumor2936. In some aspects, the lack of perfusion to the section 2987 of theintestines may be determined by means of a speckle contrast analysisbased on a Doppler analysis of blood flow into the intestines. Thenon-perfused section 2987 of the intestines may then be isolated by aseal 2985 applied to the intestine. In this manner, only those bloodvessels perfusing the tissue indicated for surgical removal may beidentified and sealed, thereby sparing healthy tissue from unintendedsurgical consequences.

In some additional aspects, a surgical visualization system may permitimaging analysis of the surgical site.

In some aspects, the surgical site may be inspected for theeffectiveness of surgical manipulation of a tissue. Non-limitingexamples of such inspection may include the inspection of surgicalstaples or welds used to seal tissue at a surgical site. Cone beamcoherent tomography using one or more illumination sources may be usedfor such methods.

In some additional aspects, an image of a surgical site may havelandmarks denoted in the image. In some examples, the landmarks may bedetermined through image analysis techniques. In some alternativeexamples, the landmarks may be denoted through a manual intervention ofthe image by the surgeon.

In some additional aspects, non-smart ready visualizations methods maybe imported for used in Hub image fusion techniques.

In additional aspects, instruments that are not integrated in the Hubsystem may be identified and tracked during their use within thesurgical site. In this aspect, computational and/or storage componentsof the Hub or in any of its components (including, for example, in thecloud system) may include a database of images related to EES andcompetitive surgical instruments that are identifiable from one or moreimages acquired through any image acquisition system or through visualanalytics of such alternative instruments. The imaging analysis of suchdevices may further permit identification of when an instrument isreplaced with a different instrument to do the same or a similar job.The identification of the replacement of an instrument during a surgicalprocedure may provide information related to when an instrument is notdoing the job or a failure of the device.

Situational Awareness

Situational awareness is the ability of some aspects of a surgicalsystem to determine or infer information related to a surgical procedurefrom data received from databases and/or instruments. The informationcan include the type of procedure being undertaken, the type of tissuebeing operated on, or the body cavity that is the subject of theprocedure. With the contextual information related to the surgicalprocedure, the surgical system can, for example, improve the manner inwhich it controls the modular devices (e.g. a robotic arm and/or roboticsurgical tool) that are connected to it and provide contextualizedinformation or suggestions to the surgeon during the course of thesurgical procedure.

Referring now to FIG. 50 , a timeline 5200 depicting situationalawareness of a hub, such as the surgical hub 106 or 206, for example, isdepicted. The timeline 5200 is an illustrative surgical procedure andthe contextual information that the surgical hub 106, 206 can derivefrom the data received from the data sources at each step in thesurgical procedure. The timeline 5200 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view (FOV) of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

As the first step 5202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

Second step 5204, the staff members scan the incoming medical suppliesfor the procedure. The surgical hub 106, 206 cross-references thescanned supplies with a list of supplies that are utilized in varioustypes of procedures and confirms that the mix of supplies corresponds toa thoracic procedure. Further, the surgical hub 106, 206 is also able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure).

Third step 5206, the medical personnel scan the patient band via ascanner that is communicably connected to the surgical hub 106, 206. Thesurgical hub 106, 206 can then confirm the patient's identity based onthe scanned data.

Fourth step 5208, the medical staff turns on the auxiliary equipment.The auxiliary equipment being utilized can vary according to the type ofsurgical procedure and the techniques to be used by the surgeon, but inthis illustrative case they include a smoke evacuator, insufflator, andmedical imaging device. When activated, the auxiliary equipment that aremodular devices can automatically pair with the surgical hub 106, 206that is located within a particular vicinity of the modular devices aspart of their initialization process. The surgical hub 106, 206 can thenderive contextual information about the surgical procedure by detectingthe types of modular devices that pair with it during this pre-operativeor initialization phase. In this particular example, the surgical hub106, 206 determines that the surgical procedure is a VATS procedurebased on this particular combination of paired modular devices. Based onthe combination of the data from the patient's EMR, the list of medicalsupplies to be used in the procedure, and the type of modular devicesthat connect to the hub, the surgical hub 106, 206 can generally inferthe specific procedure that the surgical team will be performing. Oncethe surgical hub 106, 206 knows what specific procedure is beingperformed, the surgical hub 106, 206 can then retrieve the steps of thatprocedure from a memory or from the cloud and then cross-reference thedata it subsequently receives from the connected data sources (e.g.,modular devices and patient monitoring devices) to infer what step ofthe surgical procedure the surgical team is performing.

Fifth step 5210, the staff members attach the EKG electrodes and otherpatient monitoring devices to the patient. The EKG electrodes and otherpatient monitoring devices are able to pair with the surgical hub 106,206. As the surgical hub 106, 206 begins receiving data from the patientmonitoring devices, the surgical hub 106, 206 thus confirms that thepatient is in the operating theater.

Sixth step 5212, the medical personnel induce anesthesia in the patient.The surgical hub 106, 206 can infer that the patient is under anesthesiabased on data from the modular devices and/or patient monitoringdevices, including EKG data, blood pressure data, ventilator data, orcombinations thereof, for example. Upon completion of the sixth step5212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh step 5214, the patient's lung that is being operated on iscollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commencedas it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

Eighth step 5216, the medical imaging device (e.g., a scope) is insertedand video from the medical imaging device is initiated. The surgical hub106, 206 receives the medical imaging device data (i.e., video or imagedata) through its connection to the medical imaging device. Upon receiptof the medical imaging device data, the surgical hub 106, 206 candetermine that the laparoscopic portion of the surgical procedure hascommenced. Further, the surgical hub 106, 206 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 106, 206 based on data received at the second step 5204of the procedure). The data from the medical imaging device 124 (FIG. 2) can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 106, 206), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth step 5218, the surgical team begins the dissection step of theprocedure. The surgical hub 106, 206 can infer that the surgeon is inthe process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

Tenth step 5220, the surgical team proceeds to the ligation step of theprocedure. The surgical hub 106, 206 can infer that the surgeon isligating arteries and veins because it receives data from the surgicalstapling and cutting instrument indicating that the instrument is beingfired. Similarly to the prior step, the surgical hub 106, 206 can derivethis inference by cross-referencing the receipt of data from thesurgical stapling and cutting instrument with the retrieved steps in theprocess. In certain instances, the surgical instrument can be a surgicaltool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

Twelfth step 5224, the node dissection step is then performed. Thesurgical hub 106, 206 can infer that the surgical team is dissecting thenode and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in the surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step 5224, the incisions are closed up and thepost-operative portion of the procedure begins.

Thirteenth step 5226, the patient's anesthesia is reversed. The surgicalhub 106, 206 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example.

Lastly, the fourteenth step 5228 is that the medical personnel removethe various patient monitoring devices from the patient. The surgicalhub 106, 206 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, BP, and other data from thepatient monitoring devices. As can be seen from the description of thisillustrative procedure, the surgical hub 106, 206 can determine or inferwhen each step of a given surgical procedure is taking place accordingto data received from the various data sources that are communicablycoupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is incorporated byreference herein in its entirety. In certain instances, operation of arobotic surgical system, including the various robotic surgical systemsdisclosed herein, for example, can be controlled by the hub 106, 206based on its situational awareness and/or feedback from the componentsthereof and/or based on information from the cloud 102.

Various aspects of the subject matter described herein are set out inthe following numbered examples.

Example 1

A surgical image acquisition system comprising: a plurality ofillumination sources wherein each illumination source is configured toemit light having a specified central wavelength; a light sensorconfigured to receive a portion of the light reflected from a tissuesample when illuminated by the one or more of the plurality ofillumination sources; and a computing system, wherein the computingsystem is configured to: receive data from the light sensor when thetissue sample is illuminated by each of the plurality of illuminationsources; calculate structural data related to a characteristic of astructure within the tissue sample based on the data received by thelight sensor when the tissue sample is illuminated by each of theillumination sources; and transmit the structural data related to thecharacteristic of the structure to be received by a smart surgicaldevice, wherein the characteristic of the structure is a surfacecharacteristic or a structure composition.

Example 2

The surgical image acquisition system of any one of Example 1, whereinthe plurality of illumination sources comprises at least one of a redlight illumination source, a green light illumination source, and a bluelight illumination source.

Example 3

The surgical image acquisition system of any one of Examples 1-2,wherein the plurality of illumination sources comprises at least one ofan infrared light illumination source and an ultraviolet lightillumination source.

Example 4

The surgical image acquisition system of any one of Examples 1-3,wherein the computing system, configured to calculate structural datarelated to a characteristic of a structure within the tissue, comprisesa computing system configured to calculate structural data related to acomposition of a structure within the tissue.

Example 5

The surgical image acquisition system of any one of Examples 1-4,wherein the computing system, configured to calculate structural datarelated to a characteristic of a structure within the tissue, comprisesa computing system configured to calculate structural data related to asurface roughness of a structure within the tissue.

Example 6

A surgical image acquisition system comprising: a processor; and amemory coupled to the processor, the memory storing instructionsexecutable by the processor to: control the operation of a plurality ofillumination sources of a tissue sample wherein each illumination sourceis configured to emit light having a specified central wavelength;receive data from the light sensor when the tissue sample is illuminatedby each of the plurality of illumination sources; calculate structuraldata related to a characteristic of a structure within the tissue samplebased on the data received by the light sensor when the tissue sample isilluminated by each of the illumination sources; and transmit thestructural data related to the characteristic of the structure to bereceived by a smart surgical device, wherein the characteristic of thestructure is a surface characteristic or a structure composition.

Example 7

The surgical image acquisition system of any one of Example 6, whereinthe instructions executable by the processor to control the operation ofa plurality of illumination sources comprise one or more instructions toilluminate the tissue sample sequentially by each of the plurality ofillumination sources.

Example 8

The surgical image acquisition system of any one of Example 6 throughExample 7 wherein the instructions executable by the processor tocalculate structural data related to a characteristic of a structurewithin the tissue sample based on the data received by the light sensorcomprise one or more instructions to calculate structural data relatedto a characteristic of a structure within the tissue sample based on aphase shift in the illumination reflected by the tissue sample.

Example 9

The surgical image acquisition system of any one of Examples 6-8,wherein the structure composition comprises a relative composition ofcollagen and elastin in a tissue.

Example 10

The surgical image acquisition system of any one of Examples 6-9,wherein the structure composition comprises an amount of hydration of atissue.

Example 11

A surgical image acquisition system comprising: a control circuitconfigured to: control the operation of a plurality of illuminationsources of a tissue sample wherein each illumination source isconfigured to emit light having a specified central wavelength; receivedata from the light sensor when the tissue sample is illuminated by eachof the plurality of illumination sources; calculate structural datarelated to a characteristic of a structure within the tissue samplebased on the data received by the light sensor when the tissue sample isilluminated by each of the illumination sources; and transmit thestructural data related to the characteristic of the structure to bereceived by a smart surgical device, wherein the characteristic of thestructure is a surface characteristic or a structure composition.

Example 12

The surgical image acquisition system of any one of Example 11, whereinthe control circuit is configured to transmit the structural datarelated to the characteristic of the structure to be received by a smartsurgical device wherein the smart surgical device is a smart surgicalstapler.

Example 13

The surgical image acquisition system of any one of Example 12, whereinthe control circuit is further configured to transmit data related to ananvil pressure based on the characteristic of the structure to bereceived by the smart surgical stapler.

Example 14

The surgical image acquisition system of any one of Examples 11-13,wherein the control circuit is configured to transmit the structuraldata related to the characteristic of the structure to be received by asmart surgical device wherein the smart surgical device is a smartsurgical RF sealing device.

Example 15

The surgical image acquisition system of any one of Example 14, whereinthe control circuit is further configured to transmit data related to anamount of RF power based on the characteristic of the structure to bereceived by the smart RF sealing device.

Example 16

The surgical image acquisition system of any one of Examples 11-15,wherein the control circuit is configured to transmit the structuraldata related to the characteristic of the structure to be received by asmart surgical device wherein the smart surgical device is a smartultrasound cutting device.

Example 17

The surgical image acquisition system of any one of Example 16, whereinthe control circuit is further configured to transmit data related to anamount of power provided to an ultrasonic transducer or a drivingfrequency of the ultrasonic transducer based on the characteristic ofthe structure to be received by the ultrasound cutting device.

Example 18

A non-transitory computer readable medium storing computer readableinstructions which, when executed, causes a machine to: control theoperation of a plurality of illumination sources of a tissue samplewherein each illumination source is configured to emit light having aspecified central wavelength; receive data from the light sensor whenthe tissue sample is illuminated by each of the plurality ofillumination sources; calculate structural data related to acharacteristic of a structure within the tissue sample based on the datareceived by the light sensor when the tissue sample is illuminated byeach of the illumination sources; and transmit the structural datarelated to the characteristic of the structure to be received by a smartsurgical device, wherein the characteristic of the structure is asurface characteristic or a structure composition.

While several forms have been illustrated and described, it is not theintention of the applicant to restrict or limit the scope of theappended claims to such detail. Numerous modifications, variations,changes, substitutions, combinations, and equivalents to those forms maybe implemented and will occur to those skilled in the art withoutdeparting from the scope of the present disclosure. Moreover, thestructure of each element associated with the described forms can bealternatively described as a means for providing the function performedby the element. Also, where materials are disclosed for certaincomponents, other materials may be used. It is therefore to beunderstood that the foregoing description and the appended claims areintended to cover all such modifications, combinations, and variationsas falling within the scope of the disclosed forms. The appended claimsare intended to cover all such modifications, variations, changes,substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor comprising one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

The invention claimed is:
 1. A surgical image acquisition systemcomprising: an imaging device comprising: an illumination source to emitlight having a specified central wavelength; and a light sensor toreceive a portion of light reflected from a tissue sample; a surgicalhub comprising a situational awareness module; and a computing systemcomprising a processor and a memory coupled to the processor, whereinthe memory stores machine executable instructions that when executed bythe processor cause the processor to: receive, from the imaging device,imaging data based on the light reflected from the tissue sample;calculate tissue refractive index data from the imaging data; calculatestructural data related to a characteristic of a structure within thetissue sample based on the tissue refractive index data; and transmitthe imaging data to the situational awareness module, wherein thesituational awareness module comprises an artificial intelligence moduletrained to determine a position of the imaging device based on theimaging data, and wherein the characteristic is a surface characteristicor a structure composition.
 2. The surgical image acquisition system ofclaim 1, wherein the illumination source comprises a red lightillumination source, a green light illumination source, a blue lightillumination source, an infrared light illumination source, or anultraviolet light illumination source.
 3. The surgical image acquisitionsystem of claim 1, wherein the computing system calculates structuraldata related to a percent tissue hydration.
 4. The surgical imageacquisition system of claim 1, wherein the computing system calculatesstructural data related to a surface roughness of a structure within thetissue sample.
 5. The surgical image acquisition system of claim 1,wherein the artificial intelligence module is trained to determine anorientation of the imaging device based on the imaging data.
 6. Asurgical image acquisition system comprising: an imaging devicecomprising an illumination source to emit light having a specifiedcentral wavelength; a surgical hub comprising a situational awarenessmodule; a processor; and a memory coupled to the processor, the memorystoring instructions executable by the processor to: control anoperation of the of illumination source; receive, from a light sensor,imaging data based on light reflected from a tissue sample; calculatetissue refractive index data from the imaging data; calculate structuraldata related to a characteristic of a structure within the tissue samplebased on the tissue refractive index data; and transmit the imaging datato the situational awareness module, wherein the situational awarenessmodule comprises an artificial intelligence module trained to determinea position of the imaging device based on the imaging data, and whereinthe characteristic of the structure is a surface characteristic or astructure composition.
 7. The surgical image acquisition system of claim6, wherein the instructions executable by the processor further compriseone or more instructions to calculate the structural data related to thecharacteristic of the structure within the tissue sample based on aphase shift of the light reflected from the tissue sample.
 8. Thesurgical image acquisition system of claim 6, wherein the structurecomposition comprises a relative composition of collagen and elastin inthe tissue sample.
 9. The surgical image acquisition system of claim 6,wherein the structure composition comprises an amount of hydration ofthe tissue sample.
 10. The surgical image acquisition system of claim 6,wherein the artificial intelligence module is trained to determine anorientation of the imaging device based on the imaging data.